Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
40
Countries
1
Sites
2
gastric cancer
In the study target population (stage ≥ II gastric adenocarcinomas or signet-ring cells adenocarcinomas of any stage, eligible for curative treatment), estimate the proportion of patients who present an appropriate change of TNM classification following the addition of 68Ga-FAPI-46 PET-CT to the reference examinations,…
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Bordeaux
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Decision date (initial)
- 2026-04-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Internal Call for Proposals / Appel d'Offre Interne – Bordeaux University Hospital / CHU de Bordeaux
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
In the study target population (stage ≥ II gastric adenocarcinomas or signet-ring cells adenocarcinomas of any stage, eligible for curative treatment), estimate the proportion of patients who present an appropriate change of TNM classification following the addition of 68Ga-FAPI-46 PET-CT to the reference examinations, during the initial staging (including laparoscopy)
Secondary objectives 5
- To estimate the proportion of patients with a TNM classification - determined on CT imaging alone – modified after 68Ga-FAPI-46 PET-CT
- To estimate the proportion of patients who present an appropriate change of the M status of the TNM following the addition of 68Ga-FAPI-46 PET-CT to the reference examination during the initial staging
- To estimate the proportion of patients who present an appropriate change of therapeutic management following the addition of 68Ga-FAPI-46 PET-CT to the reference examinations.
- To estimate the number of additional tumor lesions detected by 68Ga-FAPI-46 PET-CT addition to reference examinations
- To estimate inter-observer reproducibility of 68Ga-FAPI-46 PET-CT interpretation
Conditions and MedDRA coding
gastric cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Gastric cancer: stage ≥ II gastric adenocarcinoma or signet-ring cell adenocarcinoma whatever the stage, potentially requiring curative treatment
- Age > 18 years old at time of signed consent
- Beneficiary of social security insurance
- Signed informed consent by the participant and the investigator
Exclusion criteria 10
- Tumor M+ or with suspicion of distant metastasis on standard assessment
- Neoadjuvant treatment already started
- History of other active cancer
- Known contraindication to a PET examination with injection of radiopharmaceuticals (hypersensitivity to the radiopharmaceutical drug and/or excipients)
- Pregnant or breastfeeding woman
- Woman of childbearing capacity and not benefiting from effective contraception (HAS criterion)
- Person subject to a legal protection measure or unable to personally give consent
- Person in an emergency situation
- Exclusion period from another protocol
- Person deprived of liberty by judicial or administrative decision
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of patients who present an appropriate change of TNM classification, determined by initial staging following the addition of 68Ga-FAPI-46 PET-CT
Secondary endpoints 5
- Proportion of patients who present an appropriate change of the N and/or M status of the TNM, determined by standard thoraco-abdominopelvic CT imaging alone, following the addition of 68Ga-FAPI-46 PET-CT
- Proportion of patients who present an appropriate change of the M status of the TNM, determined by standard thoraco-abdominopelvic CT imaging alone, following the addition of 68Ga-FAPI-46 PET-CT
- Proportion of patients who present an appropriate addition or removal of one of the following elements of therapeutic management : curative surgical treatment, neoadjuvant or adjuvant treatment by chemotherapy or radiotherapy, surgical resection complementary, palliative treatment by chemotherapy or other systemic treatment following the addition of 68Ga-FAPI-46 PET-CT
- Average number of tumor lesions, lymph node or distant, detected by 68Ga-FAPI-46 PET-CT compared to the number of tumor lesions detected by reference staging
- Cohen's kappa coefficient measuring the inter-observer reliability of 68Ga-FAPI-46 PET/CT interpretation between coordinating center and investigating center observers.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 8
GalliaPharm 2.59 GBq radionuclide generator
PRD11500383 · Product
- Active substance
- Gallium (68GA) Chloride
- Substance synonyms
- Gallium trichloride (GA68)
- Pharmaceutical form
- RADIONUCLIDE GENERATOR
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 350 MBq megabecquerel(s)
- Max total dose
- 350 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09X — OTHER DIAGNOSTIC RADIOPHARMACEUTICALS
- Marketing authorisation
- EU/1/24/1836/005
- MA holder
- ECKERT & ZIEGLER RADIOPHARMA GMBH
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD12050460 · 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
- Substance synonyms
- 68Ga-FAPI-46
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 350 MBq megabecquerel(s)
- Max total dose
- 350 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX
- Paediatric formulation
- No
- Orphan designation
- No
GalliaPharm 3.33 GBq radionuclide generator
PRD11500397 · Product
- Active substance
- Gallium (68GA) Chloride
- Substance synonyms
- Gallium trichloride (GA68)
- Pharmaceutical form
- RADIONUCLIDE GENERATOR
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 350 MBq megabecquerel(s)
- Max total dose
- 350 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09X — OTHER DIAGNOSTIC RADIOPHARMACEUTICALS
- Marketing authorisation
- EU/1/24/1836/007
- MA holder
- ECKERT & ZIEGLER RADIOPHARMA GMBH
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
GalliaPharm 1.85 GBq radionuclide generator
PRD11500350 · Product
- Active substance
- Gallium (68GA) Chloride
- Substance synonyms
- Gallium trichloride (GA68)
- Pharmaceutical form
- RADIONUCLIDE GENERATOR
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 350 MBq megabecquerel(s)
- Max total dose
- 350 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09X — OTHER DIAGNOSTIC RADIOPHARMACEUTICALS
- Marketing authorisation
- EU/1/24/1836/003
- MA holder
- ECKERT & ZIEGLER RADIOPHARMA GMBH
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Galliad, 0,74 à 1,85 GBq, générateur radiopharmaceutique
PRD7292120 · Product
- Active substance
- Germanium (68GE) Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 350 MBq megabecquerel(s)
- Max total dose
- 350 MBq megabecquerel(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- V09X — OTHER DIAGNOSTIC RADIOPHARMACEUTICALS
- Marketing authorisation
- 34009 550 579 0 1
- MA holder
- IRE ELIT
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
GalliaPharm 2.22 GBq radionuclide generator
PRD11500372 · Product
- Active substance
- Gallium (68GA) Chloride
- Substance synonyms
- Gallium trichloride (GA68)
- Pharmaceutical form
- RADIONUCLIDE GENERATOR
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 350 MBq megabecquerel(s)
- Max total dose
- 350 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09X — OTHER DIAGNOSTIC RADIOPHARMACEUTICALS
- Marketing authorisation
- EU/1/24/1836/004
- MA holder
- ECKERT & ZIEGLER RADIOPHARMA GMBH
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
GalliaPharm 3.70 GBq radionuclide generator
PRD11500402 · Product
- Active substance
- Gallium (68GA) Chloride
- Substance synonyms
- Gallium trichloride (GA68)
- Pharmaceutical form
- RADIONUCLIDE GENERATOR
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 350 MBq megabecquerel(s)
- Max total dose
- 350 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09X — OTHER DIAGNOSTIC RADIOPHARMACEUTICALS
- Marketing authorisation
- EU/1/24/1836/008
- MA holder
- ECKERT & ZIEGLER RADIOPHARMA GMBH
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
GalliaPharm 2.96 GBq radionuclide generator
PRD11500391 · Product
- Active substance
- Gallium (68GA) Chloride
- Substance synonyms
- Gallium trichloride (GA68)
- Pharmaceutical form
- RADIONUCLIDE GENERATOR
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 350 MBq megabecquerel(s)
- Max total dose
- 350 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09X — OTHER DIAGNOSTIC RADIOPHARMACEUTICALS
- Marketing authorisation
- EU/1/24/1836/006
- MA holder
- ECKERT & ZIEGLER RADIOPHARMA GMBH
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Bordeaux
- Sponsor organisation
- Centre Hospitalier Universitaire De Bordeaux
- Address
- 12 Rue Dubernat
- City
- Talence
- Postcode
- 33400
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Bordeaux
- Contact name
- Ghoufrane TLILI
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Bordeaux
- Contact name
- Ghoufrane TLILI
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 40 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Regional Du Cancer De Montpellier
Médecine Nucléaire, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Centre Hospitalier Universitaire De Bordeaux
Médecine Nucléaire, 66 Avenue De Magellan, 33608, Pessac Cedex
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-524434-25-00 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF patient | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF patient TC | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | H1_RCP Galliapharm | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | H1_RCP Galliapharm | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | H1_RCP Galliapharm | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | H1_RCP Galliapharm | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | H1_RCP Galliapharm | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | H1_RCP Galliapharm | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-524434-25-00 | 1.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-18 | France | Acceptable 2026-04-30
|
2026-04-30 |