Clinical Trials Register

Summary
EudraCT Number:	2018-000398-64
Sponsor's Protocol Code Number:	VHIO18001
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-04-20
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

Spain - AEMPS

A.2

EudraCT number

2018-000398-64

A.3

Full title of the trial

Patterns of uptake of 18F-FDG and 68Ga-DOTA PET in advanced neuroendoctrine tumors

Identificación de los diferentes patrones de captación mediante PET con 18F-FDG y 68Ga-DOTA-péptidos en los tumores neuroendocrinos avanzados

A.3.1

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

Comparison of PET (radiological test) with 18F-FDG and with 68Ga-DOTA-peptides in advanced neuroendocrine tumors

Comparativa de PET (prueba radiológica) con 18F-FDG y con 68Ga-DOTA-péptidos en los tumores neuroendocrinos avanzados

A.4.1

Sponsor's protocol code number

VHIO18001

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	Vall d' Hebron Institute of Oncology (VHIO)
B.1.3.4	Country	Spain
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	Advanced Accelerator Applications
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Vall d' Hebron Institute of Oncology (VHIO)
B.5.2	Functional name of contact point	Clinical Research Support Unit
B.5.3	Address:
B.5.3.1	Street Address	C/ Natzaret, 115-117
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08035
B.5.3.4	Country	Spain
B.5.4	Telephone number	34932 543 4508614
B.5.5	Fax number	34934894212
B.5.6	E-mail	smunoz@vhio.net

D. IMP Identification
D.IMP: 1
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	Yes
D.2.1.1.1	Trade name	SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation
D.2.1.1.2	Name of the Marketing Authorisation holder	Advanced Accelerator Applications
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/15/1450
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Kit for radiopharmaceutical preparation
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	Edotreotide
D.3.9.3	Other descriptive name	GALLIUM (68GA) EDOTREOTIDE
D.3.9.4	EV Substance Code	SUB183602
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	100 to 200
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.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

Gastroenteropancreatic neuroendocrine tumor disease

Tumores neuroendocrinos gastroenteropancreáticos

E.1.1.1

Medical condition in easily understood language

Gastroenteropancreatic neuroendocrine tumor disease

Tumores neuroendocrinos gastroenteropancreáticos

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10077560
E.1.2	Term	Gastroenteropancreatic neuroendocrine tumor disease
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

1-To determine the sensitivity of 68Ga-DOTA PET-CT to detect tumors with high expression of RSST as compared to that of standard of care with octreotide labeled with gamma-emitting radionuclides
2- To identify the uptake patterns of 18F-FDG and 68Ga-DOTA PET-CT within subjects with well or moderately differentiated metastatic GEP-NET (ENETS grades 1 and 2).
3-To establish the correlation between the functional characteristics of hepatic lesions and the level of uptake of 18F-FDG and 68Ga.
4-To explore the impact of this combined imaging test on therapeutics.

1-Analizar el incremento de eficacia diagnóstica de la PET-TC con 68Ga-DOTA en la identificación de lesiones que expresan RSST respecto al “standart of care” que se realiza mediante estudios con octreótido marcado con emisores gamma.
2-Determinar los diferentes patrones de fijación de 18F-FDG y de péptidos 68Ga-DOTA mediante PET-TC en un mismo individuo con metástasis de GEPNET bien y moderadamente diferenciados (grados 1 y 2 de la clasificación de la ENETS).
3-Correlacionar las características de imagen funcional de las lesiones hepáticas entre el nivel de fijación de 18F-FDG y péptidos 68Ga.
4-Valorar el impacto terapéutico que en el futuro podría desprenderse de la incorporación de esta metodología combinada.

E.2.2

Secondary objectives of the trial

Not applicable

No aplicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

The study population will be composed of 30 patients with metastatic NET. A total of 15 patients with primary pancreatic tumor and 15 with primary extra-pancreatic tumor will be included.
Inclusion criteria:
1. Age > 18 years.
2. Signed informed consent form.
3. Grade 1 and 2 NETs according to WHO and ENETS classification.
4. Metastatic NETs.
5. Life expectancy > 12 months.

La población del estudio la compondrán 30 pacientes con NET metastáticos. Se incluiran 15 pacientes con primario de origen pancreático y 15 pacientes con primario de origen extra-pancreático.
Los criterios de inclusión serán:
1. Pacientes > 18 años.
2. Pacientes que hayan firmado el consentimiento informado.
3. NETs de Grados 1 y 2 según las clasificaciones de la WHO y ENETS.
4. NETs con metástasis.
5. Esperanza de vida > 12 meses.

E.4

Principal exclusion criteria

1. Grade 3 NET according to WHO and ENETS classification.
2. Previous systemic radiopharmaceutical therapy.
4. Pregnancy
5. High-risk disease (cardiovascular, pulmonary...)
6. Chronic liver disease

1. NETs de Grado 3 según las clasificaciones de la WHO y ENETS.
2. Pacientes que ya hayan recibido un tratamiento sistémico con radiofármacos.
4. Embarazo
5. Enfermedad de alto riesgo (cardiovascular, pulmonar...)
6. Hepatopatía crónica

E.5 End points

E.5.1

Primary end point(s)

1. Number of new lesions detected with PET-CT with 68Ga-DOTA compared to PET-CT with 18F-FDG.

2. Number of affected organs detected with PET-CT with 68Ga-DOTA compared to PET-CT with 18F-FDG

1. Número de nuevas lesiones detectadas con la PET-TC con 68Ga-DOTA respecto a la PET-TC con 18F-FDG.

2. Número de órganos afectados detectados con la PET-TC con 68Ga-DOTA respecto a la PET-TC con 18F-FDG.

E.5.1.1

Timepoint(s) of evaluation of this end point

Both comparative imaging studies will be performed after having performed both tests in each of the patients included in the trial.

Ambos estudios comparativos de imagen se realizarán tras haber realizado ambas pruebas en cada uno de los pacientes incluidos en el ensayo.

E.5.2

Secondary end point(s)

None

Ninguno

E.5.2.1

Timepoint(s) of evaluation of this end point

None

Ninguno

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.8.2.4

Number of treatment arms in the trial

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

2 days after the patient has undergone PET-CT PET-CT with 68Ga-DOTA-peptides

2 días después de que el paciente se haya sometido al PET-TC PET-TC con 68Ga-DOTA-péptidos

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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.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)

Not applicable

No aplicable

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

2018-06-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-06-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-12-02

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