Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07629609

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pancreatic Cancer, Adult Adenocarcinoma Carcinoma Carcinoma, Signet Ring Cell Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastroesophageal Cancer (GC) Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Cystic, Mucinous, and Serous Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

Location status: Recruiting

Location contact

Barbara M Fischer, professor, Professor, MD, Ph.D.

CONTACT

Marie M K Stolberg, MD

CONTACT

[email protected]

+45 35454416 ext. +45 35453545

Marie M K Stolberg, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for group A

  • 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

Inclusion criteria

for group B1

  • Male or female over 18 years old
  • 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

Inclusion criteria

for group B2

  • 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

Exclusion criteria

  • 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

Treatment and study plan

[68Ga]Ga-FAPI-46

Drug

PET/CT scan with the tracer [68Ga]Ga-FAPI-46

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. Estimated potential impact/change in patient management.

    Time frame: From the time of scan to the end of follow up at 1 year

  3. 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

    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

  1. Patients' experience of a [68Ga]Ga-FAPI-46 Total Body PET/CT compared to standard imaging modalities.

    Time frame: 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).

  2. Uptake of [68Ga]Ga-FAPI-46 from lesions suspicious of malignancy wil be correlated with progression free survival (PFS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie M K Stolberg, MD

CONTACT

[email protected]

+4535454416

Sponsors and collaborators

Lead sponsor

Barbara Malene Fischer

Other

Collaborators

  • Danish Cancer Society
  • Herlev Hospital

Registry information

Official study title

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

Acronym: BEFAST

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.