BEFAST Study, [68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer

• [68Ga]Ga-FAPI-46 (Drug): PET/CT scan with the tracer \[68Ga\]Ga-FAPI-46

Primary outcomes

• Sensitivity of [68Ga]Ga-FAPI-46 Total Body PET/CT [From the time of scan to the end of follow up at 1 year]: Sensitivity of lesions suspicious of malignancy of \[68Ga\]Ga-FAPI-46 Total Body 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). Sensitivity will be measured as the proportion of true positive malignant findings on \[68Ga\]Ga-FAPI-46 Total Body PET/CT within 30 mins of injection of the tracer. This will be done, by comparing the lesions suspicious of malignancy found on \[68Ga\]Ga-FAPI-46 PET/CT, and standard imaging with the results from the curative surgery and/or a composed reference standard, which consist of all available imaging, 6 months follow up and blinded expert opinion.

Secondary outcomes

• Accuracy measurements of [68Ga]Ga-FAPI-46 Total Body PET/CT [From the time of scan to the end of follow up at 1 year]: Sensitivity of lesions suspicious of malignancy of \[68Ga\]Ga-FAPI-46 Total Body PET/CT after 60 min of injection of the tracer, as well as accuracy, specificity, positive predictive value (PPV) and negative predictive value (NPV). Sensitivity (the proportion of true positive findings), specificity (the proportion of true negative findings), PPV (the proportion of positive findings, which are true positives) and NPV (the proportion of negative findings which are true negatives will be measured by comparing the lesions suspicious of malignancy found on \[68Ga\]Ga-FAPI-46 PET/CT and standard imaging with the results from the curative surgery and/or a composed reference standard, which is composed of all available imaging, 6 months follow up and blinded expert opinion.
• Estimated potential impact/change in patient management. [From the time of scan to the end of follow up at 1 year]
• Description of FAPI-uptake from lesions suspicious of malignancy. [From the time of scan to the end of follow up at 1 year]: FAPI-uptake in lesions suspicious of malignancy will be described and quantified with standardized uptake values (SUV, e.g. SUVmax, SUVmean). SUV is a ratio of the concentration of the tracer in a region of interest on the scan and the concentration of tracer injected in the participant.

Other outcomes

• Patients' experience of a [68Ga]Ga-FAPI-46 Total Body PET/CT compared to standard imaging modalities. [Immediately after completion of the scan (single time point)]: Patients will be given a small questionnaire immediately after the \[68Ga\]Ga-FAPI-46 TB PET/CT, to fill out by his or herself (please refer to the appendix 2 in the protocol). The questionnaire is inspired by a questionnaire from a previous study exploring patient experiences during an \[18F\]FDG PET/CT and with inspiration from local and national questionnaires on patient experience during visits to radiology departments provided by the Capital Region of Denmark. The questionnaire includes 6 questions, 2 regarding patient information, 3 questions regarding stress and anxiety during the exmination and 1 question regarding the expectations to the scan. The different questions is rated on a descriptive scale (Very Much, Quite a lot, Some, Not at all).
• Uptake of [68Ga]Ga-FAPI-46 from lesions suspicious of malignancy wil be correlated with progression free survival (PFS) [From the time of scan to the end of follow up at 1 year]: FAPI-uptake (measured as Standardised uptake value \[SUV\], which is a ratio of the concentration of the tracer in a region of interest on the scan and the concentration of tracer injected in the patient) in lesions suspicious of malignancy will be correlated with PFS after 1 year follow-up. PFS is defined as the time from the \[68Ga\]Ga-FAPI-46 TB PET/CT to progression of cancer disease, recurrence of cancer disease, or death of any cause.

Sex: All, ages: 18 Years to any

Inclusion criteria for group A

1. Male or female, over 18 years old
2. Patients with suspected pancreatic cancer based on morphological findings on standard imaging
3. CT or 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 B1

1. Male or female over 18 years old
2. Histological verified carcinoma from the lower esophagus, 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

Inclusion criteria for group B2

1. Male or female over 18 years old
2. Histological verified SRCC or PCC from the lower esophagus, GEJ, or stomach
3. Subjects with localized disease assigned to perioperative chemotherapy or subjects with metastatic disease assigned to palliative systemic treatment.
4. Subjects must be able to read and understand the patient information in Danish to give informed consent

Exclusion Criteria:

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 composition of \[68Ga\]Ga-FAPI-46

• Study Protocol and Statistical Analysis Plan (PDF, 2024-05-24)
• Informed Consent Form: gastroesophageal cancer and pancreatic cancer (PDF, 2024-05-24)

NIH grants: 2023