Clinical trial • Phase IV • Other
GALLIUM (68GA) CHLORIDE for Inflammatory disorders
Phase IV trial of GALLIUM (68GA) CHLORIDE for Inflammatory disorders. 390 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Inflammatory disorders
- Trial Stage
- Phase IV
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 09-08-2024
- First CTIS Authorization Date
- 20-11-2024
Trial design
Phase IV trial across 1 site in France.
- Target Sample Size
- 390
Eligibility
Recruits 390 Vulnerable population not selected; participants must be aged 18 or over; 'Patients unable to consent' are explicitly excluded. Subject information and informed consent form document is listed. No provisions for assent or parental consent are mentioned in the available record..
- Pregnancy Exclusion
- • Pregnant or breastfeeding woman
- Vulnerable Population
- Vulnerable population not selected; participants must be aged 18 or over; 'Patients unable to consent' are explicitly excluded. Subject information and informed consent form document is listed. No provisions for assent or parental consent are mentioned in the available record.
Inclusion criteria
- {"criterion_text":"- •\tPatient aged 18 or over"}
- {"criterion_text":"- •\tAffected by one of the pathologies concerned by the study"}
- {"criterion_text":"- •\tMeeting consensus classification criteria for pathology"}
- {"criterion_text":"- •\tSatisfying the corresponding clinical situation"}
Exclusion criteria
- {"criterion_text":"- •\tPregnant or breastfeeding woman"}
- {"criterion_text":"- •\tPatients unable to consent"}
- {"criterion_text":"- •\tPatients refusing to participate in research"}
- {"criterion_text":"- •\tKnown active cancer"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Binding intensity in TEP, measured by the Standardized uptake value (SUV) max.","definition_or_measurement_approach":"Measured by the Standardized uptake value (SUV) max on PET/CT"}
Secondary endpoints
- {"endpoint_text":"- To meet the first secondary objective: - Measurement of fixation intensity in PET and measurement of pathology-specific reference score (if applicable).","definition_or_measurement_approach":"Measurement of fixation intensity in PET and measurement of pathology-specific reference score (if applicable)."}
- {"endpoint_text":"- To meet the second secondary objective: - Measurement of fixation intensity in PET and measurement of other pathology-specific assessment scores (if applicable)","definition_or_measurement_approach":"Measurement of fixation intensity in PET and measurement of other pathology-specific assessment scores (if applicable)."}
- {"endpoint_text":"- To meet the third secondary objective: - Measurement of PET fixation intensity and measurement of pathology-specific biomarkers (if applicable)","definition_or_measurement_approach":"Measurement of PET fixation intensity and measurement of pathology-specific biomarkers (if applicable)."}
- {"endpoint_text":"- To meet the fourth secondary objective: - Measurement of PET fixation intensity and measurement of pathology-specific functional parameters (if applicable)","definition_or_measurement_approach":"Measurement of PET fixation intensity and measurement of pathology-specific functional parameters (if applicable)."}
- {"endpoint_text":"- To meet the fifth secondary objective: - Measurement of PET fixation intensity and assessment of pathology-specific imaging characteristics (if applicable)","definition_or_measurement_approach":"Measurement of PET fixation intensity and assessment of pathology-specific imaging characteristics (if applicable)."}
- {"endpoint_text":"- 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","definition_or_measurement_approach":"Measurement of [68Ga] Ga-FAPI PET/CT fixation intensity and measurement of [18F] F-FDG PET/CT fixation intensity at M0."}
- {"endpoint_text":"- To address the seventh secondary objective: - Evaluation of [68Ga] Ga-FAPI tracer uptake kinetics in PET according to different pathologies and their phenotypic characteristics.","definition_or_measurement_approach":"Evaluation of tracer uptake kinetics of [68Ga] Ga-FAPI in PET according to different pathologies and phenotypic characteristics."}
- {"endpoint_text":"- To meet cross-cutting secondary objectives: - Measurement of [68Ga] Ga-FAPI PET/CT fixation intensity and measurement of SF-36 questionnaire score","definition_or_measurement_approach":"Measurement of [68Ga] Ga-FAPI PET/CT fixation intensity and measurement of SF-36 questionnaire score."}
- {"endpoint_text":"- - Measurement of [68Ga] Ga-FAPI PET/CT fixation intensity and measurement of global disease assessment.","definition_or_measurement_approach":"Measurement of [68Ga] Ga-FAPI PET/CT fixation intensity and measurement of global disease assessment."}
Recruitment
- Planned Sample Size
- 390
- Recruitment Window Months
- 24
- Consent Approach
- Written informed consent by the participant is required; participants must be aged 18 or over and 'Patients unable to consent' are excluded. A subject information and informed consent form document (L1_SIS and ICF subjects PARADISE) is listed. No details on assent, parental consent, or languages are provided in the available record.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 390
France
- Earliest CTIS Part Ii Submission Date
- 12-11-2024
- Latest Decision Or Authorization Date
- 03-03-2026
- Processing Time Days
- 476
- Number Of Sites
- 1
- Number Of Participants
- 390
Sites
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Service de Médecine Nucléaire
- Principal Investigator Name
- Pierre-Yves LE ROUX
- Principal Investigator Email
- pierre-yves.leroux@chu-brest.fr
- Contact Person Name
- Pierre-Yves LE ROUX
- Contact Person Email
- pierre-yves.leroux@chu-brest.fr
Sponsor
Primary sponsor
- Full Name
- CHU de Brest
- Organisation Type
- Health care
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- GALLIUM (68GA) CHLORIDE
- Active Substance
- GALLIUM (68GA) CHLORIDE
- Modality
- Radiopharmaceutical
- Routes Of Administration
- SOLUTION FOR INJECTION
- Route
- SOLUTION FOR INJECTION
- Authorisation Status
- 2
- Maximum Dose
- 400 MBq
- Investigational Product Name
- 68-FAPI-46
- Active Substance
- (S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-CYANO-4,4-DIFLUOROPYRROLIDIN-1-YL)-2-OXOETHYLCARBAMOYL)-QUINOLIN-6-YL)(METHYL)AMINO)-PROPYL)PIPERAZIN-1-YL)-2-OXOETHYL)-68GA-[1,4,7,10]-TETRAAZACYCLODODECANE-1,4,7-TRIYL)TRIACETATE
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INJECTABLE SOLUTION
- Route
- INJECTABLE SOLUTION
- Authorisation Status
- 1
- Maximum Dose
- 400 MBq
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