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

[68Ga]Ga-FAPI Total Body PET/CT for Improving Diagnostic Sensitivity and Preoperative Staging in Gastroesophageal Cancer and Pancreatic Cancer

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:

• Is [68Ga]Ga-FAPI-46 Total Body PET/CT better at diagnosing metastatic disease in the abdomen compared other imaging modalities?
• Can [68Ga]Ga-FAPI-46 Total Body PET/CT produce accurate images in less than 30 min?

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:

• One [68Ga]Ga-FAPI Total Body PET/CT before surgery (Group A), or before laparoscopy (group B1), or before oncological treatment (Group B2).
• Participants in group B2 will also undergo a second [68Ga]Ga-FAPI-46 Total Body PET/CT during treatment with chemotherapy.
• All participants will fill out one questionnaire.
• Researchers will follow the patients after the scans for 1 year.

Study Overview

• Status: Recruiting
• Conditions: Gastroesophageal Cancer (GC); Pancreatic Cancer, Adult
• Intervention / Treatment: Drug: [68Ga]Ga-FAPI-46

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Marie M K Stolberg, MD; Phone Number: +4535454416; Email: marie.manon.krebs.krarup@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Rigshospitalet
    • Contact: Marie M K Stolberg, MD; Phone Number: +45 35453545 +45 35454416; Email: marie.manon.krebs.krarup@regionh.dk
    • Contact: Barbara M Fischer, professor, Professor, MD, Ph.D.
    • Sub-Investigator: Marie M K Stolberg, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cancer patients	Drug: [68Ga]Ga-FAPI-46; PET/CT scan with the tracer [68Ga]Ga-FAPI-46

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the time of scan to the end of follow up at 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the time of scan to the end of follow up at 1 year
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.	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.	From the time of scan to the end of follow up at 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	From the time of scan to the end of follow up at 1 year

Collaborators and Investigators

• Sponsor: Barbara Malene Fischer
• Collaborators: Danish Cancer Society; Herlev Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: September 10, 2025
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: PET/CT; pancreatic cancer; gastroesophageal cancer; FAPI; signet ring cell carcinoma
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Neoplasms, Cystic, Mucinous, and Serous; Pancreatic Neoplasms; Carcinoma, Signet Ring Cell; Pancreatic cancer, adult
• Other Study ID Numbers: 523_22; 2023-503632-41-01 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No