Clinical trial • Phase II • Oncology|Other

(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 for ER-positive breast cancer

Phase II trial of (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)PIPERAZI…

Overview

Trial Therapeutic Area
Oncology|Other
Trial Disease
ER-positive breast cancer
Trial Stage
Phase II
Drug Modality
Radiopharmaceutical

Key dates

Initial CTIS Submission Date
15-11-2024
First CTIS Authorization Date
18-03-2025

Trial design

Test: 68Ga-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) - route: INTRAVENOUS BOLUS USE; dose unit MBq/kg; max daily dose 3 MBq/kg; max total dose 495 MBq. Comparator: Steripet 250 MBq/ml Oplossing voor injectie (Fludeoxyglucose (18F)) - route: INJECTION; dose unit MBq/kg; max total dose 450 MBq (marketing authorisation RVG 33033).-controlled Phase II trial across 1 site in Netherlands.

Comparator
Test: 68Ga-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) - route: INTRAVENOUS BOLUS USE; dose unit MBq/kg; max daily dose 3 MBq/kg; max total dose 495 MBq. Comparator: Steripet 250 MBq/ml Oplossing voor injectie (Fludeoxyglucose (18F)) - route: INJECTION; dose unit MBq/kg; max total dose 450 MBq (marketing authorisation RVG 33033).
Target Sample Size
20

Eligibility

Recruits 20 No vulnerable populations selected. Participants must have personally provided written informed consent; inability to provide informed consent is an exclusion. Minimum age is 18 (Age <18. is excluded)..

Pregnancy Exclusion
Pregnancy.
Vulnerable Population
No vulnerable populations selected. Participants must have personally provided written informed consent; inability to provide informed consent is an exclusion. Minimum age is 18 (Age <18. is excluded).

Inclusion criteria

  • {"criterion_text":"- Female patient with histopathologically proven ER+ breast cancer.\n- Diagnosed with locally advanced breast cancer (primary tumor >5 cm and/or presence of axillary lymph node metastases) or recurrent breast cancer, or metastatic breast cancer for which 18F-FDG PET/CT or 18F-FDG PET/MRI staging is performed.\n- Willing and able to undergo the study procedures.\n- Has personally provided written informed consent."}

Exclusion criteria

  • {"criterion_text":"- Age <18.\n- Pregnancy.\n- Patients with secondary malignancies (except non-melanoma skin cancer).\n- No 18F-FDG PET/CT or 18F-FDG PET/MRI scan.\n- Contra-indications for PET/MRI such as pacemaker, aneurysm clips, metallic device in their body, severe claustrophobia, and severe obesity\n- Inability to provide informed consent.\n- Chronic inflammatory disease such as rheumatoid arthritis.\n- Patients with severe hepatic or renal impairment (eGFR ≤45mL/min/1.73m²)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The proportion of discordant pairs: How many lesions are detected on the 68Ga-FAPI-46 PET scan but not on the 18F-FDG PET scan and how many lesions are detected on the 18F-FDG PET scan but not on the 68Ga-FAPI-46 PET scan?","definition_or_measurement_approach":"Proportion of discordant lesion pairs between the two PET tracers, i.e. count lesions detected by one tracer and not the other; compare numbers of lesions per patient/lesion to determine discordance."}

Secondary endpoints

  • {"endpoint_text":"- To investigate the proportion of 68Ga-FAPI-46-positive 18F-FDG-negative lesions for which performing a biopsy is not feasible.","definition_or_measurement_approach":"Proportion of lesions that are 68Ga-FAPI-46-positive and 18F-FDG-negative where biopsy is judged not feasible (feasibility assessed as part of study procedures)."}

Recruitment

Planned Sample Size
20
Recruitment Window Months
36
Consent Approach
Participants must personally provide written informed consent ("Has personally provided written informed consent."). Inability to provide informed consent is an exclusion. Minimum age 18 applies; no assent procedures described. Subject information and informed consent form document is listed (L1_SIS and ICF_redacted).

Geography

Total Number Of Sites
1
Total Number Of Participants
20

Netherlands

Earliest CTIS Part Ii Submission Date
18-02-2025
Latest Decision Or Authorization Date
23-06-2025
Processing Time Days
125
Number Of Sites
1
Number Of Participants
20

Sites

Site Name
Maastricht University Medical Center
Department Name
Radiology and Nuclear Medicine
Principal Investigator Name
Thiemo van Nijnatten
Principal Investigator Email
thiemo.nijnatten@mumc.nl
Contact Person Name
Thiemo van Nijnatten
Contact Person Email
thiemo.nijnatten@mumc.nl
Number Of Participants
20

Sponsor

Primary sponsor

Full Name
University Hospital Maastricht
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
68Ga-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
INTRAVENOUS BOLUS USE
Route
INTRAVENOUS BOLUS USE
Authorisation Status
MIA: DE_SN_01_MIA_2024_0015 (investigational/test product)
Maximum Dose
Max daily dose 3 MBq/kg; max total dose 495 MBq
Investigational Product Name
Steripet 250 MBq/ml Oplossing voor injectie
Active Substance
FLUDEOXYGLUCOSE (18F)
Modality
Radiopharmaceutical
Routes Of Administration
INJECTION
Route
INJECTION
Authorisation Status
Marketing authorisation RVG 33033 (prodAuthStatus: 2)
Maximum Dose
Max total dose 450 MBq

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