[AL[18F]F]FAPI-74 for Oesophagogastric adenocarcinoma | Pancreatic ductal adenocarcinoma | Other solid malignancies (clinically challenging cases)

Inclusion criteria

• {"criterion_text":"- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.\n- Age 18 or older.\n- For OGA: New histologic or cytologic proven diagnosis of oesophagogastric adenocarcinoma. + Patient underwent a [18F]FDG PET/CT or is planned to have one in the following 4 weeks. + TNM classification: cT1-4N0-3M0\n- For PDAC: New histologic or cytologic proven diagnosis of pancreatic ductal adenocarcinoma. + Patient underwent a [18F]FDG PET/CT or is planned to have one in the following 4 weeks or patient underwent/is planned to have conventional staging with (upper) abdomen CT or (upper) abdomen MRI in the following 4 weeks. + TNM classification: cT1-4N0-2M0-1, with the exception of upfront resectable patients.\n- For the oncology patients with a clinically challenging situation: Histologic or cytologic proven diagnosis of a malignancy. + Patient underwent a [18F]FDG PET/CT of is planned to have one in the following 4 weeks. + Unexplained symptoms, complaints, biochemical or imaging (scintigraphy, PET, CT, MR) findings."}

Exclusion criteria

• {"criterion_text":"- Participant is mentally or legally incapacitated, doesn’t understand the study design or is not willing or capable to undergo all study-specific procedures.\n- Any disorder or condition, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol.\n- Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial.\n- Female who is pregnant (urinary hCG test can be performed in case of doubt), breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive (with a relatively high Pearl Index: natural methods, minipill outside postpartum period, spermicides or condoms in monotherapy or no usage of contraception when sexually active are not accepted).\n- Participation in an interventional Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by the study team.\n- Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv.\n- For PDAC: Patient is upfront resectable."}

Primary endpoints

• {"endpoint_text":"- OGA: detection ratio for lymph node and distant metastases (combined).","definition_or_measurement_approach":"Measured as detection ratio of [18F]AlF-FAPI-74 PET/CT for lymph node and distant metastases compared to [18F]FDG PET/CT or conventional imaging (reference standard) in treatment-naïve, newly diagnosed OGA patients."}
• {"endpoint_text":"- PDAC: detection ratio for lymph node and distant metastases (combined).","definition_or_measurement_approach":"Measured as detection ratio of [18F]AlF-FAPI-74 PET/CT for lymph node and distant metastases compared to [18F]FDG PET/CT or conventional imaging (reference standard) in treatment-naïve, newly diagnosed PDAC patients."}
• {"endpoint_text":"- Clinically Challenging Situation: fraction of patients were scan was deemed contributory. This means: 1.\t[18F]AlF-FAPI-74 identifies a lesion as malignant (true positive) with effective upstaging. 2.\t[18F]AlF-FAPI-74 identifies a lesion as non-malignant (true negative) with effective downstaging. 3.\t[18F]AlF-FAPI-74 can differentiate between a malignant or non-malignant lesion when there is doubt. 4.\tOther implications that are deemed contributory by the treating physician.","definition_or_measurement_approach":"Measured as the fraction of clinically challenging-case patients for whom the [18F]AlF-FAPI-74 PET/CT scan was judged contributory by the treating physician based on the listed criteria (true positive upstaging, true negative downstaging, differentiation in doubtful cases, or other clinically contributory implications)."}

Secondary endpoints

• {"endpoint_text":"- See trial synopsis","definition_or_measurement_approach":""}

Belgium

Earliest CTIS Part Ii Submission Date

28-11-2024

Latest Decision Or Authorization Date

20-02-2025

Processing Time Days

84

Number Of Sites

3

Number Of Participants

109

Primary sponsor

Full Name

UZ Leuven

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium

Third parties

• {"country":"","full_name":"SOFIE","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Kom Op Tegen Kanker","duties_or_roles":"Monetary support","organisation_type":""}