68Gallium-FAPI PET/CT imaging in Chronic inflammatory and fibrotic diseases (PARADISE study)

2023-508190-84-01 Protocol 29BRC23.0029 Therapeutic exploratory (Phase II) Ongoing, recruiting

Start 13 Mar 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol 29BRC23.0029

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruiting
Participants planned 390
Countries 1
Sites 1

Inflammatory disorders

To describe the sites and fixation intensity of [68Ga] Ga-FAPI PET/CT examinations performed at M0 in the 13 targeted chronic inflammatory and/or fibrosing diseases.

Key facts

Sponsor
CHU de Brest
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
Trial duration
13 Mar 2025 → ongoing
Decision date (initial)
2024-11-20
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2023-508190-84-01
ClinicalTrials.gov
NCT06275477

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic

To describe the sites and fixation intensity of [68Ga] Ga-FAPI PET/CT examinations performed at M0 in the 13 targeted chronic inflammatory and/or fibrosing diseases.

Secondary objectives 10

  1. Specific to each study population: - To study the correlation between the fixation intensity obtained in [68Ga] Ga-FAPI PET/CT and the reference pathology assessment score.
  2. - To study the correlation between [68Ga] Ga-FAPI PET/CT fixation intensity and other pathology assessment parameters.
  3. - To study the correlation between [68Ga] Ga-FAPI PET/CT fixation intensity and the main biomarkers of the pathology.
  4. - To study the correlation between the fixation intensity obtained in [68Ga] Ga-FAPI PET/CT and the functional parameters of the pathology.
  5. - To study the correlation between [68Ga] Ga-FAPI PET/CT fixation intensity and the imaging characteristics of the pathology.
  6. - Describe the evolution of [68Ga] Ga-FAPI PET/CT parameters between M0 and M3 (*).
  7. - Compare the results of [68Ga] Ga-FAPI PET/CT and [18F] F-FDG PET/CT at M0 (**).
  8. - Study the kinetics of [68Ga] Ga-FAPI tracer uptake in PET according to different pathologies and their phenotypic characteristics.
  9. Transversal for all inflammatory pathologies: - Study the correlation between [68Ga] Ga-FAPI PET/CT fixation intensity and quality of life
  10. - Study the correlation between [68Ga] Ga-FAPI PET/CT fixation intensity and overall disease assessment

Conditions and MedDRA coding

Inflammatory disorders

Regulatory references

Plan to share IPD
No
EU CT numberTitleSponsor
2023-508190-84-00 68Gallium-FAPI PET/CT imaging in Chronic inflammatory and fibrotic diseases (PARADISE study) CHU de Brest

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. • Patient aged 18 or over
  2. • Affected by one of the pathologies concerned by the study
  3. • Meeting consensus classification criteria for pathology
  4. • Satisfying the corresponding clinical situation

Exclusion criteria 4

  1. • Pregnant or breastfeeding woman
  2. • Patients unable to consent
  3. • Patients refusing to participate in research
  4. • Known active cancer

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Binding intensity in TEP, measured by the Standardized uptake value (SUV) max.

Secondary endpoints 9

  1. To meet the first secondary objective: - Measurement of fixation intensity in PET and measurement of pathology-specific reference score (if applicable).
  2. To meet the second secondary objective: - Measurement of fixation intensity in PET and measurement of other pathology-specific assessment scores (if applicable)
  3. To meet the third secondary objective: - Measurement of PET fixation intensity and measurement of pathology-specific biomarkers (if applicable)
  4. To meet the fourth secondary objective: - Measurement of PET fixation intensity and measurement of pathology-specific functional parameters (if applicable)
  5. To meet the fifth secondary objective: - Measurement of PET fixation intensity and assessment of pathology-specific imaging characteristics (if applicable)
  6. To meet the sixth secondary objective: - Measurement of [68Ga] Ga-FAPI PET/CT fixation intensity and measurement of [18F] F-FDG PET/CT fixation intensity at M0
  7. To address the seventh secondary objective: - Evaluation of [68Ga] Ga-FAPI tracer uptake kinetics in PET according to different pathologies and their phenotypic characteristics.
  8. To meet cross-cutting secondary objectives: - Measurement of [68Ga] Ga-FAPI PET/CT fixation intensity and measurement of SF-36 questionnaire score
  9. - Measurement of [68Ga] Ga-FAPI PET/CT fixation intensity and measurement of global disease assessment.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

68-FAPI-46

PRD10973218 · Product

Active substance
(S-222-10-2-4-3-4-2-2-CYANO-44-DIFLUOROPYRROLIDIN-1-YL-2-OXOETHYLCARBAMOYL-QUINOLIN-6-YLMETHYLAMINO-PROPYLPIPERAZIN-1-YL-2-OXOETHYL-68GA-14710-TETRAAZACYCLODODECANE-147-TRIYLTRIACETATE
Pharmaceutical form
INJECTION
Route of administration
INJECTABLE SOLUTION
Max daily dose
200 MBq megabecquerel(s)
Max total dose
400 MBq megabecquerel(s)
Max treatment duration
1 Day(s)
Authorisation status
Not Authorised
MA holder
CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE BREST
Paediatric formulation
No
Orphan designation
No

Gallium (68GA) Chloride

SUB170788 · Substance

Active substance
Gallium (68GA) Chloride
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
200 MBq megabecquerel(s)
Max total dose
400 MBq megabecquerel(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

CHU de Brest

Sponsor organisation
CHU de Brest
Address
2 Avenue Foch
City
BREST
Postcode
29200
Country
France

Scientific contact point

Organisation
CHU de Brest
Contact name
Pr Pierre-Yves LE ROUX

Public contact point

Organisation
CHU de Brest
Contact name
Julien DOLOU

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ongoing, recruiting 390 1
Rest of world — 0 —

Investigational sites

France

1 site · Ongoing, recruiting
Centre Hospitalier Regional Et Universitaire De Brest
Service de Médecine Nucléaire, Boulevard Tanguy Prigent, 29200, Brest

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2025-03-13 2025-03-13

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_PROTOCOL_2023-508190-84-00 3.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Subject information and informed consent form (for publication) L1_SIS and ICF subjects PARADISE 4.1
Subject information and informed consent form (for publication) L2_Other subject information material addendum_2023-508190-84 1
Summary of Product Characteristics (SmPC) (for publication) 2023-508190-84_00_SmPC_Galliapharm 68Ga 1
Synopsis of the protocol (for publication) D1_PROTOCOLE_SYNOPSIS_EN_2023-508190-84-00 3.0
Synopsis of the protocol (for publication) D1_PROTOCOLE_SYNOPSIS_FR_2023-508190-84-00 3.0

Application history

7 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-08-09 France Acceptable
2024-11-05
 2024-11-20
2 NON SUBSTANTIAL MODIFICATION NSM-1 2025-03-07 France Acceptable
2024-11-05
 2025-03-07
3 SUBSTANTIAL MODIFICATION SM-3 2025-03-28 France Acceptable 2025-04-08
4 SUBSTANTIAL MODIFICATION SM-4 2025-04-08 France Acceptable 2025-04-09
5 SUBSTANTIAL MODIFICATION SM-5 2025-06-03 France Acceptable 2025-06-17
6 SUBSTANTIAL MODIFICATION SM-6 2025-11-21 France Acceptable
2026-02-26
 2026-03-03
7 SUBSTANTIAL MODIFICATION SM-7 2026-03-24 France Acceptable
2026-05-26
 2026-06-01

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