A Phase 2 interventional study of [68Ga]Ga-FAPI-46 in Pancreatic Cancer, Adult and Gastroesophageal Cancer (GC), sponsored by Barbara Malene Fischer. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Barbara Malene Fischer · Phase 2, Interventional, and Diagnostic
The goal of this clinical trial is to learn if [68Ga]Ga-FAPI-46 Total Body PET/CT can diagnose patients suffering from gastroesophageal cancer and pancreatic cancer. The investigators hope that [68Ga]Ga-FAPI-46 Total Body PET/CT can improve staging and treatment evaluation for these patient groups.
The main questions the trial aims to answer are:
Researchers will examine three different patient groups:
Group A) patients with pancreatic cancer, who are referred to surgery. Group B1) patients with gastroesophageal cancer, who are referred to diagnostic surgery (laparoscopy).
Group B2) a subgroup of gastroesophageal cancer patients, with a specific subtype cancer (signet ring cell carcinoma or poorly cohesive carcinoma), who are referred to oncological treatment.
Participants will undergo:
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's planned enrollment of 90 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Barbara Malene Fischer is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for group A
Inclusion criteria for group B1
Inclusion criteria for group B2
Exclusion Criteria:
Drug: [68Ga]Ga-FAPI-46
PET/CT scan with the tracer \[68Ga\]Ga-FAPI-46
Sensitivity of [68Ga]Ga-FAPI-46 Total Body PET/CT
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.
Time frame: From the time of scan to the end of follow up at 1 year
Accuracy measurements of [68Ga]Ga-FAPI-46 Total Body PET/CT
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.
Time frame: From the time of scan to the end of follow up at 1 year
Estimated potential impact/change in patient management.
Time frame: From the time of scan to the end of follow up at 1 year
Description of FAPI-uptake from lesions suspicious of malignancy.
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.
Time frame: From the time of scan to the end of follow up at 1 year
Patients' experience of a [68Ga]Ga-FAPI-46 Total Body PET/CT compared to standard imaging modalities.
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).
Time frame: Immediately after completion of the scan (single time point)
Uptake of [68Ga]Ga-FAPI-46 from lesions suspicious of malignancy wil be correlated with progression free survival (PFS)
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.
Time frame: From the time of scan to the end of follow up at 1 year
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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Pancreatic cancer, adult
Barbara Malene Fischer