Clinical Trials Register

Summary
EudraCT Number:	2013-004886-14
Sponsor's Protocol Code Number:	2013092981
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-05-27
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Denmark - DHMA

A.2

EudraCT number

2013-004886-14

A.3

Full title of the trial

MET-PET-study - Comparative study of Tc-99m- sestamibi SPECT/ldCT with C-11-L-Methionin PET/diagnostic CT and theri ability to locate paratyroid adenomas preoperatively.

MET-PET-studiet - Sammenlignende studie af parathyroideascintigrafi i form af Tc-99m- sestamibi SPECT/ldCT med C-11-L-Methionin PET/diagnostisk CT ved lokalisationsdiagnostik forud for operation for primær hyperparathyroidisme.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

MET-PET-study - A comparative study of Tc-99m- sestamibi SPECT/ldCT and C-11-L-Methionin PET/diagnostic CT and their ability to locate paratyroid adenomas preoperatively.

MET-PET-studiet - Et sammenlignende studie af parathyroideascintigrafi i form af Tc-99m- sestamibi SPECT/ldCT med C-11-L-Methionin PET/diagnostisk CT ved lokalisationsdiagnostikforud for operation for primær hyperparathyroidisme.

A.3.2

Name or abbreviated title of the trial where available

MET-PET

A.4.1

Sponsor's protocol code number

2013092981

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Dep. Nuclear medicine, Odense university hospital
B.1.3.4	Country	Denmark
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Dep.nuclear medicine, Odense university hospital
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Dep.nuclear medicine, Odense university hospital
B.5.2	Functional name of contact point	sys.vestergaard@rsyd.dk
B.5.3	Address:
B.5.3.1	Street Address	Sdr.boulevard 29
B.5.3.2	Town/ city	Odense C.
B.5.3.3	Post code	5000
B.5.3.4	Country	Denmark
B.5.4	Telephone number	4565412980
B.5.6	E-mail	sys.vestergaard@rsyd.dk

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Stamicis
D.2.1.1.2	Name of the Marketing Authorisation holder	Dupharma
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	N/A
D.3.4	Pharmaceutical form	Infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TECHNETIUM (99MTC) SESTAMIBI
D.3.9.1	CAS number	109581-73-9
D.3.9.2	Current sponsor code	Technetium-99m-methoxyisobutylisonitrile
D.3.9.3	Other descriptive name	MIBI
D.3.9.4	EV Substance Code	SUB10857MIG
D.3.10	Strength
D.3.10.1	Concentration unit	MBq megabecquerel(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	700
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	Yes
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	C-11-L-Methionin
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	C-11-L-Methionin
D.3.9.1	CAS number	63-68-3
D.3.9.2	Current sponsor code	C-11-L-Methionin
D.3.9.3	Other descriptive name	L-METHIONINE
D.3.9.4	EV Substance Code	SUB21984
D.3.10	Strength
D.3.10.1	Concentration unit	MBq megabecquerel(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	420 to 560
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	Yes
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Preoperative localisation of hyperfunctioning parathyroid tissue in suspected primary hyperparathyroidism.

Præoperativ lokalisationsdiagnostik af hyperfungerende parathyroideavæv mistænkt primær hyperparathyroidisme.

E.1.1.1

Medical condition in easily understood language

Preoperative localisation of hyperfunctioning parathyroid tissue in suspected primary hyperparathyroidism.

Præoperativ lokalisationsdiagnostik af hyperfungerende parathyroideavæv mistænkt primær hyperparathyroidisme.

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.1
E.1.2	Level	LLT
E.1.2	Classification code	10036693
E.1.2	Term	Primary hyperparathyroidism
E.1.2	System Organ Class	100000004860

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

MET-PET-study - Comparative study of Tc-99m- sestamibi SPECT/ldCT with C-11-L-Methionine PET/diagnostic CT and their ability to locate hyerpunctioning paratyroid tissue preoperatively in suspected primary hyperparathyroidism.

MET-PET-Studiet - Sammenlignende studie af Tc-99m-sestamibi SPECT/ldCT med C-11-L-Methionin PET/diagnostisk CT mht deres evne til præoperativ lokalisationsdiagnostik af hyperfungerende parathyroideavæv ved mistænkt primær hyperparathyridisme.

E.2.2

Secondary objectives of the trial

N/A

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Men and women above the age of 18 years who are referred to our department for preoperative localisation of hyperfunctioning parathyroid tissue prior to operation for suspected primary hyperparathyroidism.

Mænd og kvinder over 18 år som er henvist til vores afdeling mhp lokalisationsdiagnostik af hyperfungerende parathyroideavæv forud for planlagt operation for mistænkt primær hyperparathyroidisme.

E.4

Principal exclusion criteria

Suspected secondary and tertiary hyperparathyroidism.
Suspected Familiar hypocalciuria hypercalcemia.
Suspected Familiar Hyperparathyroidism.
Suspected multiple endocrine neoplasia (MEN)
Patients treated with Lithium and / or Mimpara
Pregnancy.
Known allergy to the tracers infused.
Known allergy to iodine containing contrast agents.
Persons 18 years or younger.
Former operation / radiotherapy towards the neck.
If the prathyroidscintigraphy is cancelled or there is more than a forthnight between the two examniations.
If the patient has undergone operation between the two examinations.
If the patient is not operated within 12 months after completing the two examinations.
Inhability - if the person does not speak and understand danish to a degree acceptable to participate or has cognitive problems that complicates active participation.
If there is no signed consent to participate or the concent has been withdrawn.

Mistænkt sekundær og tertiær hyperparathyroidisme.
Mistænkt Familiær Hypercalciurisk Hypercalcæmi.
Mistænkt Familiær Hyperparathyroidisme.
Mistænkt Multiple Endokrin Neoplasi.
Patienter i behandling med Litium and / or Mimpara.
Graviditet.
Kendt allergi overfor tracerne der infunderes.
Kendt allergi overfor iodholdige kontrastmidler
Personer 18 år eller yngre.
Tidligere operation eller radioterapi mod halsen.
Hvis parathyroideascintigrafien aflyses eller der er mere end 14 dage mellem de to undersøgelser.
Hvis patienten er blevet opereret mellem de to undersøgelser.
Hvis patienten ikke bliver opereret indenfor 12 måned efter at have gennemført de to undersøgelser.
Inhabilitet - hvis personen ikke taler og forstår dansk i tilstrækkelig grad til at medvirke, eller har kognitive problemer som hindrer aktiv medvirken.
Manglende eller tilbagetrukket samtykke.

E.5 End points

E.5.1

Primary end point(s)

Comparison of Tc-99m-sestamibi SPECT/ld-CT to C-11-L-Methionin PET/diagnostic-CT. Golden standard being peroperative findings of localisation and PTH-measurements, combined with histopathological findings.
The evaluation of each examination is conducted by at least two M.D's, who carry out the daily description of such examinations and with at least one having senior nuclear medicine expertise and an exsperienced radiologist in regard to description of diagnostic CT. Each is blinded to the other set of images but not to other imaging modalities. Ultimately a consensus-based description of each patient is made after the evaluation of each examination is complete. The consensus-based description is consistent with answers given to the referring party.
The evaluations are based on visual assessments regarding detection and localisation of hyperfunctioning parathyroid tissue in suspected primary hyperparathyroidism in relation to routine descriptions of the examinations. The basis of the evaluation is comprised of the following parameter;
Primary endpoint:
Detection of hyperfunctioning parathyroid tissue and evaluation of level of certainty in this detection divided into five categories.
1.Certain pathology 2. Predominantly certain pathology 3. Intermediate risk of pathology 4. Predominantly no pathology 5. No pathology.

PET/diagnostisk-CT. Golden standard er peroperative lokalisationsfund og PTH-målinger, kombineret med histopatologiske fund. Hver undersøgelse evalueres af mindst to læger i rutinen, som alle har erfaring med beskrivelse af undersøgelserne og hvoraf mindst en er speciallæge og ligeledes af en speciallæge i radiologi ved bedømmelse af den diagnostiske CT. Undersøgelserne beskrives blindet i forhold til den anden undersøgelse, men ikke overfor andre billedmodaliteter. Tilslut udformes et samlet svar for undersøgelserne til henvisende afdeling, men først når hver undersøgelse er færdigevalueret for angivne endepunkter.
Evalueringen Sammenlignende studie af Tc-99m-sestamibi SPECT/ld-CT og C-11-L-Methionin for hver undersøgelse består af en visuel bedømmelse mht detektion og lokalisation af hyperfungerende parathyroideavæv ved mistænkt primær hyperparathyroidisme i rutinen. Evalueringen bygger på følgende parametre.
Primære endepunkter:
Detektion af hyperfungerende parathyroideavæv og evaluering af detektionssikkerheden bedømt ud fra fem kategorier;
1. Sikkert adenom 2. Forementlig adenom 3. I tvivl 4. Formentlig negativ 5. Sikkert negativ.

E.5.1.1

Timepoint(s) of evaluation of this end point

Evaluation of the imaging results is performed continuously.

Evaluering af undersøgelsesresultaterne foregår kontinuert.

E.5.2

Secondary end point(s)

Secondary endpoints:
- Localisation of hyperfunctioning parathyroid tissue, by marking on a phantomdrawing, divided into 11 regions;
1.Right kraniel 2. Right central 3. Right kaudal 4. Left kraniel 5.Left central 6.Left kaudal 7.Istmus 8. Ectopic caput 9. Ectopic collum 10. Ectopic Thorax 11. No adenoma
- The certainty by which the localisation can be pointed out or not - specified on a scale 1-5.

Sekundære endepunkter:
- Lokalisering af hyperfungerende parathyroideavæv, ved markering på en fantomtegning, opdels i 11 regioner;
1. Højre kranielt 2. Højre centralt 3.Højre kaudalt 4.Venstre kranielt 5. Venstre centralt 6.Venstre kaudalt 7. Istmus 8. Ektopisk caput 9. Ektopisk collum 10. Ektopisk Thorax 11. Intet adenom påvist.
- Sikkerheden hvormed denne lokalisering kan angives eller ikke angives, anført på en skala 1-5.

E.5.2.1

Timepoint(s) of evaluation of this end point

Evaluation of the imaging results is performed continuously.

Evaluering af undersøgelsesresultaterne foregår kontinuert.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Standard treatment plan.

Standard behandling.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-07-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-08-22

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-07-13

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