(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 Peritoneal metastases

Inclusion criteria

• {"criterion_text":"- A planned start of repeated IP chemotherapy (with or without the combination of systemic chemotherapy) for macroscopic peritoneal metastases\n- WHO-performance score of 0 to 1\n- Aged 18 years or older\n- Written informed consent according to the ICH-GCP and national/local regulations"}

Exclusion criteria

• {"criterion_text":"- Impaired renal function, defined as eGFR <25 ml/min/1,73 m2. An exception can be made in consultation with the treating physician\n- Pregnancy/breastfeeding. For the latter, temporary discontinuation may be considered\n- Known allergic reaction to therapeutic radiopharmaceuticals\n- Inability to lie still on the back for the duration of PET-CT\n- Any (other) condition, disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that may affect the interpretation of the results, or which might contribute substantially to the patient's experience of study burden (such as non-suppressible claustrophobia)"}

Primary endpoints

• {"endpoint_text":"- The accuracy will be calculated as the sensitivity of the ⁶⁸Ga-FAPI PET/CT with clinical assessment during MTB and/or histopathological outcome at second laparoscopy as a reference standard.","definition_or_measurement_approach":"Calculated as the sensitivity of the ⁶⁸Ga-FAPI PET/CT with clinical assessment during MTB and/or histopathological outcome at second laparoscopy as reference standard."}

Secondary endpoints

• {"endpoint_text":"- The absolute change in peritoneal tumor size or volume as measured by imaging before and after treatment.","definition_or_measurement_approach":"Absolute change in peritoneal tumor size or volume measured by imaging before and after treatment."}

Netherlands

Earliest CTIS Part Ii Submission Date

18-08-2025

Latest Decision Or Authorization Date

18-08-2025

Processing Time Days

0

Number Of Sites

1

Number Of Participants

16

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands