Clinical trial • Phase II • Oncology

(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
Trial Disease
ER-positive breast cancer
Trial Stage
Phase II
Drug Modality
Radiopharmaceutical

Key dates

Initial CTIS Submission Date
28-03-2024
First CTIS Authorization Date
08-07-2024

Trial design

18F-FDG PET (standard tracer) versus 68Ga-FAPI-46 PET (investigational tracer). 68Ga-FAPI-46 administered intravenously (intravenous bolus use); dosing information available: dose unit MBq/kg, max daily dose amount 3 MBq/kg, max total dose 495 MBq. No dosing schedule specified for 18F-FDG in the record.-controlled Phase II trial across 1 site in Netherlands.

Comparator
18F-FDG PET (standard tracer) versus 68Ga-FAPI-46 PET (investigational tracer). 68Ga-FAPI-46 administered intravenously (intravenous bolus use); dosing information available: dose unit MBq/kg, max daily dose amount 3 MBq/kg, max total dose 495 MBq. No dosing schedule specified for 18F-FDG in the record.
Target Sample Size
10

Eligibility

Recruits 10 No vulnerable populations selected; participants must personally provide written informed consent. Age <18 excluded; inability to provide informed consent excluded. No assent procedures or other vulnerable-population consent handling described..

Pregnancy Exclusion
Pregnancy.
Vulnerable Population
No vulnerable populations selected; participants must personally provide written informed consent. Age <18 excluded; inability to provide informed consent excluded. No assent procedures or other vulnerable-population consent handling described.

Inclusion criteria

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

Exclusion criteria

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

Endpoints

Primary endpoints

  • {"endpoint_text":"- To investigate the number of lesions detected on 18F-FDG PET but not on 68Ga-FAPI-46 PET and the number of lesions detected on 68Ga-FAPI-46 PET but not on 18F-FDG PET.","definition_or_measurement_approach":"Comparison of lesion counts detected by each PET tracer (number of lesions detected on one modality but not the other) as assessed on PET imaging."}

Secondary endpoints

  • {"endpoint_text":"- To investigate the number of lesions detected on 68Ga-FAPI-46 PET/CT but not on 68Ga-FAPI-46 PET/MRI and vice versa.","definition_or_measurement_approach":"Comparison of lesion counts between 68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI (number of lesions detected on one modality but not the other) as assessed on imaging."}

Recruitment

Planned Sample Size
10
Recruitment Window Months
35
Consent Approach
Participants must personally provide written informed consent. Minors (Age <18) are excluded. No assent procedures, age-specific consent documents, or languages for consent are specified.

Geography

Total Number Of Sites
1
Total Number Of Participants
10

Netherlands

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
08-07-2024
Processing Time Days
13
Number Of Sites
1
Number Of Participants
10

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
10

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
Authorisation Status
MIA DE_SN_01_MIA_2024_0015
Maximum Dose
3 MBq/kg (max total 495 MBq)

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