2023-503632-41-00
Withdrawn
Phase 2
BEFAST STUDY: [68Ga]Ga-FAPI total body PET/CT for Better and Faster imaging in cancer Protocol: [68Ga]Ga-FAPI total body PET/CT for improving diagnostic sensitivity and preoperative staging in gastroesophageal cancer and pancreatic cancer
Overview
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Rigshospitalet
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 1) Sensitivity of lesions suspicious of malignancy of [68Ga]Ga-FAPI-46 TB PET/CT within 30 min of injection of the tracer compared with the sensitivity of current standard imaging modalities ([18F]FDG PET/CT, CT, MRI).
Overview
Brief Summary
The overall aim of the study is to evaluate the diagnostic sensitivity of the tracer [68Ga]Ga-FAPI-46 with total body (TB) positron emission tomography (PET)/computed tomography (CT) compared to standard imaging in patients with gastroesophageal cancer and pancreatic cancer.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion criteria for group A 1)Male or female, =/>18 years old 2)Patients with suspected pancreatic cancer based on morphological findings on standard imaging 3)CT, MRI or [18F]FDG PET/CT evaluated on MDT with no initial sign of distant metastases 4) Subjects must have been considered suitable for curative surgery at the time of the referral 5)Subjects must be able to read and understand the patient information in Danish to give informed consent. Inclusion criteria for group B 1)Male or female =/>18 years old 2)Histological verified carcinoma from the lower oesophagus, GEJ or stomach 3)Subjects must be considered operable and resectable at the time of referral for MDT 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 1) Pregnancy or lactation 2)Weight more than the maximum limit of a PET/CT-scanner bed ( 140 kg) 3)History of allergic reaction due to compounds similar to the chemical or biological composition of [68Ga]Ga-FAPI-
- •Exclusion criteria for group B 1)The subject is not considered suitable for diagnostic laparoscopy and potentially curative treatment at the MDT-conference 2)Pregnancy or lactation 3)Weight more than the maximum limit of a PET/CT-scanner bed ( 140 kg) 4)History of allergic reaction due to compounds similar to the chemical or biological composition of [68Ga]Ga-FAPI-46
Outcomes
Primary Outcomes
1) Sensitivity of lesions suspicious of malignancy of [68Ga]Ga-FAPI-46 TB PET/CT within 30 min of injection of the tracer compared with the sensitivity of current standard imaging modalities ([18F]FDG PET/CT, CT, MRI).
1) Sensitivity of lesions suspicious of malignancy of [68Ga]Ga-FAPI-46 TB PET/CT within 30 min of injection of the tracer compared with the sensitivity of current standard imaging modalities ([18F]FDG PET/CT, CT, MRI).
Secondary Outcomes
- 1) Sensitivity of lesions suspicious of malignancy of [68Ga]Ga-FAPI-46 TB PET/CT after 60 min, as well as accuracy, specificity, positive predictive value (PPV) and negative predictive value (NPV) 2) Estimated potential impact/change in patient management 3)Description of FAPI-uptake from lesions suspicious of malignancy
Investigators
Barbara Malene Fischer
Scientific
Rigshospitalet
Study Sites (1)
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