CTIS2023-503632-41-01RecruitingPhase 1
BEFAST STUDY: [68Ga]Ga-FAPI total body PET/CT for Better and Faster imaging in cancerProtocol: [68Ga]Ga-FAPI total body PET/CT for improving diagnostic sensitivity and preoperative staging in gastroesophageal cancer and pancreatic cancer
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Rigshospitalet
- Enrollment
- 90
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •Inclusion criteria for group A: 1)Male or female, =/>18 years old, Inclusion criteria for group B2: 1)Male or female, =/>18 years old, Inclusion criteria for group B2: 2)Histological verified SRCC or PCC from the lower esophagus, GEJ, or stomach, Inclusion criteria for group B2: 3)Subjects with localized disease assigned to perioperative chemotherapy or subjects with metastatic disease assigned to palliative systemic treatment., Inclusion criteria for group B2: 4)Subjects must be able to read and understand the patient information in Danish to give informed consent, Inclusion criteria for group A: 2)Patients with suspected pancreatic cancer based on morphological findings on standard imaging, Inclusion criteria for group A: 3)CT or MRI or [18F]FDG PET/CT evaluated on MDT with no initial sign of distant metastases, Inclusion Criteria for group A: 4)Subjects must have been considered suitable for curative surgery at the time of the referral, Inclusion criteria for group A: 5)Subjects must be able to read and understand the patient information in Danish to give informed consent, Inclusion criteria for group B1: 1)Male or female, =/>18 years old, Inclusion criteria for group B1: 2)Histological verified carcinoma from the lower esophagus, GEJ, or stomach, Inclusion criteria for group B1: 3)Subjects must be considered operable and resectable at the time of referral for MDT, Inclusion criteria for group B1: 4)Subjects must be able to read and understand the patient information in Danish to give informed consent
Exclusion Criteria
- •Exclusion criteria for group A+B: 1)Pregnancy or lactation, Exclusion criteria for group A+B: 2)Weight more than the maximum limit of a PET/CT-scanner bed (140 kg), Exclusion criteria for group A+B: 3)History of allergic reaction due to compounds similar to the chemical composition of [68Ga]Ga-FAPI-46
Investigators
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