Pancreatic Cancer, AdultPhase 2BEFASTNCT07629609
BEFAST Study, [68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer
A Phase 2 study testing [68Ga]Ga-FAPI-46 in people with Pancreatic Cancer, Adult and Gastroesophageal Cancer (GC), run by Barbara Malene Fischer at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Adult, Gastroesophageal Cancer (GC)
- What is being tested?
- [68Ga]Ga-FAPI-46
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Jan 2024to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, over 18 years old
- Patients with suspected pancreatic cancer based on morphological findings on standard imaging
- CT or MRI or [18F]FDG PET/CT evaluated on MDT with no initial sign of distant metastases
- Subjects must have been considered suitable for curative surgery at the time of the referral
- Subjects must be able to read and understand the patient information in Danish to give informed consent
- Male or female over 18 years old
Show all 13Show fewer
- Histological verified carcinoma from the lower esophagus, GEJ, or stomach
- Subjects must be considered operable and resectable at the time of referral for MDT
- Subjects must be able to read and understand the patient information in Danish to give informed consent
- Male or female over 18 years old
- Histological verified SRCC or PCC from the lower esophagus, GEJ, or stomach
- Subjects with localized disease assigned to perioperative chemotherapy or subjects with metastatic disease assigned to palliative systemic treatment.
- Subjects must be able to read and understand the patient information in Danish to give informed consent
Who cannot join
- Pregnancy or lactation
- Weight more than the maximum limit of a PET/CT-scanner bed (140 kg)
- History of allergic reaction due to compounds similar to the chemical composition of [68Ga]Ga-FAPI-46
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Marie M K Stolberg, MD, +45 35454416 ext. +45 35453545, marie.manon.krebs.krarup@regionh.dk
Barbara M Fischer, professor, Professor, MD, Ph.D.
About this study
Official title: [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:
Read more
- 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.
- Being tested
- [68Ga]Ga-FAPI-46
- Keywords
- PET/CT, FAPI, pancreatic cancer, gastroesophageal cancer, signet ring cell carcinoma
- Medical subject headings
- Pancreatic cancer, adult, Pancreatic Neoplasms, Carcinoma, Signet Ring Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-FAPI-46Drug
PET/CT scan with the tracer [68Ga]Ga-FAPI-46
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients | Experimental | Not described Receives: Drug: [68Ga]Ga-FAPI-46 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the time of scan to the end of follow up at 1 year
Secondary outcomes (3)
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.
Measured: From the time of scan to the end of follow up at 1 year
Estimated potential impact/change in patient management.
Measured: 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.
Measured: From the time of scan to the end of follow up at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start16 Jan 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barbara Malene Fischer
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, Herlev Hospital
- Responsible party
- Sponsor-investigator, Barbara Malene Fischer, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629609
- Sponsor's protocol ID
- 523_22
- Other IDs
- 2023-503632-41-01, 2023
- Acronym
- BEFAST
- Status last verified
- Jun 2026
- First submitted
- 10 Sep 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [68Ga]Ga-FAPI Total Body PET/CT for Improving Diagnostic Sensitivity and Preoperative Staging in Gastroesophageal Cancer and Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07629609
- Acronym / sponsor ID
- BEFAST / 523_22
- Keywords
- PET/CT, FAPI, pancreatic cancer, gastroesophageal cancer, signet ring cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Barbara Malene FischerUniversity, hospital or other
- Collaborators
- Danish Cancer Society, Herlev Hospital
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | Experimental | Drug: [68Ga]Ga-FAPI-46 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female, over 18 years old
- Patients with suspected pancreatic cancer based on morphological findings on standard imaging
- CT or MRI or [18F]FDG PET/CT evaluated on MDT with no initial sign of distant metastases
- Subjects must have been considered suitable for curative surgery at the time of the referral
- Subjects must be able to read and understand the patient information in Danish to give informed consent
Key exclusion criteria (3 listed)
- Pregnancy or lactation
- Weight more than the maximum limit of a PET/CT-scanner bed (140 kg)
- History of allergic reaction due to compounds similar to the chemical composition of [68Ga]Ga-FAPI-46
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-FAPI-46PET/CT scan with the tracer [68Ga]Ga-FAPI-46 | Drug | Cancer patients |
Primary outcome
Sensitivity of [68Ga]Ga-FAPI-46 Total Body PET/CT
Time frame: 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.
3 secondary outcomes
Accuracy measurements of [68Ga]Ga-FAPI-46 Total Body PET/CT
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.
Time frame: From the time of scan to the end of follow up at 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Cancer, Adult
RecruitingPhase 1
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
RecruitingObservational study
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer
RecruitingPhase 1/2
JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration
Advanced Solid Tumors
RecruitingPhase 1/2
A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors
Pancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer
RecruitingPhase 1
A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in Adults With Advanced or Metastatic Solid Tumors
Advanced or Metastatic Solid Tumors, Triple Negative Breast Cancer (TNBC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [68Ga]Ga-FAPI-46 in people with Pancreatic Cancer, Adult and Gastroesophageal Cancer (GC), run by Barbara Malene Fischer at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie M K Stolberg, MD (+4535454416, marie.manon.krebs.krarup@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of [68Ga]Ga-FAPI-46 Total Body PET/CT (time frame: From the time of scan to the end of follow up at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.