Clinical Trials Register

Summary
EudraCT Number:	2021-002224-20
Sponsor's Protocol Code Number:	29BRC21.0131
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-04-26
Trial 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

France - ANSM

A.2

EudraCT number

2021-002224-20

A.3

Full title of the trial

PET / CT of pulmonary perfusion with Gallium68 for the preservation of pulmonary function during pulmonary stereotaxic radiotherapy.

TEP/TDM de perfusion pulmonaire au Gallium68 pour la préservation de la fonction pulmonaire lors de la radiothérapie stéréotaxique pulmonaire.

A.3.1

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

PET / CT of pulmonary perfusion with Gallium68 for the preservation of pulmonary function during pulmonary stereotaxic radiotherapy.

TEP/TDM de perfusion pulmonaire au Gallium68 pour la préservation de la fonction pulmonaire lors de la radiothérapie stéréotaxique pulmonaire.

A.3.2

Name or abbreviated title of the trial where available

PEGASUS

A.4.1

Sponsor's protocol code number

29BRC21.0131

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	CHRU de Brest
B.1.3.4	Country	France
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	CHRU de Brest
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	CHRU de BREST
B.5.2	Functional name of contact point	Rachel VERDET
B.5.3	Address:
B.5.3.1	Street Address	DRI - CHRU de Brest, Hôpital Morvan - 2 avenue Foch
B.5.3.2	Town/ city	Brest cedex
B.5.3.3	Post code	29609
B.5.3.4	Country	France
B.5.4	Telephone number	+33229020090
B.5.5	Fax number	+33298223183
B.5.6	E-mail	rachel.verdet@chu-brest.fr

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	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	68Ga-macroagrégats d'albumine humaine
D.3.2	Product code	[68Ga-MAA]
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
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	Yes
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

Non-small cell lung cancer (NSCLC) or lung metastases

Cancer bronchique non à petites cellules (CBNPC) ou métastases pulmonaires

E.1.1.1

Medical condition in easily understood language

Non-small cell lung cancer (NSCLC) or lung metastases

Cancer bronchique non à petites cellules (CBNPC) ou métastases pulmonaires

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10038738
E.1.2	Term	Respiratory, thoracic and mediastinal disorders
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Estimer le % de patients pour lesquels il est possible, tout en respectant les contraintes standards (volume cible, organes sains dont le poumon anatomique), de réduire la dose au poumon fonctionnel.

E.2.2

Secondary objectives of the trial

- Estimer le % de patients pour lesquels il est possible, tout en respectant les contraintes standards, de réduire la dose au poumon fonctionnel, chez les patients présentant une fonction pulmonaire normale (VEMS>60).
- Estimer le % de patients pour lesquels il est possible, tout en respectant les contraintes standards, de réduire la dose au poumon fonctionnel, chez les patients présentant une fonction pulmonaire pathologique (VEMS<60).
- Évaluer le % de diminution de dose au poumon fonctionnel entre une planification anatomique et une planification fonctionnelle.
- Evaluer la proportion de patients présentant une toxicité pulmonaire ≥G2 à 3, 6, 9 et 12 mois.
- Evaluer si les doses au poumon fonctionnel sont prédictives de la toxicité pulmonaire.
- Evaluer l’impact de la SBRT sur la perfusion pulmonaire régionale à 3 mois et à 12 mois.
- Evaluer parmi les patients adressés pour SBRT, la proportion de patients présentant une altération de la fonction pulmonaire (VEMS>60).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients d'âge supérieur à 18 ans, assuré social, traité par SBRT pour une lésion primitive ou secondaire au CHRU de Brest.

E.4

Principal exclusion criteria

1) Incapacité/refus de donner son consentement
2) Femmes enceintes ou allaitant
3) Patient sous tutelle ou curatelle

E.5 End points

E.5.1

Primary end point(s)

% de patients pour lesquels il est possible de réduire la dose au poumon fonctionnel (estimé lors de la planification fonctionnelle).

Une réduction de la dose au poumon fonctionnel sera définie par :
- Une diminution d’au moins 5% du volume fonctionnel pulmonaire inclue dans la V20Gy.
ou
- Une diminution d’au moins 5% de la fonction pulmonaire relative incluse dans la V20Gy.

E.5.1.1

Timepoint(s) of evaluation of this end point

between V0 ( inclusion visit) and V1 (1 month after radiotherapy)

Entre V0 ( visite inclusion ) et V1 (1 mois après radiothérapie)

E.5.2

Secondary end point(s)

TEP/TDM de perfusion pulmonaire :
% d’activité incluse dans la V20Gy lors de la planification anatomique et lors de la planification fonctionnelle.
% du volume fonctionnel pulmonaire inclue dans la V20Gy lors de la planification anatomique et lors de la planification fonctionnelle.

Toxicité pulmonaire définie selon les critères de l’EORTC (CTCAE 5.0, EORTC QLQ-C30, EORTC QLQ-LC13) à 3, 6, 9 et 12 mois

Dyspnée (EQ-5D-5L, EFR, TM-6minutes) à V0, puis à 3, 6, 9 et 12 mois

E.5.2.1

Timepoint(s) of evaluation of this end point

Between V0 ( inclusion visit) and V1 (1 monts after radiotherapy) for anatomic and fonctional planifications
At 3, 6, 9 and 12 months after radiotherapy for pulmonary toxicity
At inclusion visit (V0) and 3, 6, 9 and 12 months after radiotherapy for dyspnea

Entre V0 ( visite inclusion ) et V1 (1 mois après radiothérapie) pour la planification anatomique et fonctionnelle
A 3, 6, 9 and 12 mois post-radiothérapie pour la toxicité pulmonaire
A l'inclusion (V0) et 3, 6, 9 and 12 mois post-radiothérapie pour la dyspnée

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

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

Yes

E.6.13.1

Other scope of the trial description

exploratory / pilot feasibility study

étude exploratoire/pilote de faisabilité

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

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

Yes

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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)

none

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

2021-07-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-05-11

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-02-28

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