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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBarbara Malene Fischer

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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 design

Treatments tested in this trial

  • [68Ga]Ga-FAPI-46

Treatment groups

90 Participants
are divided into 1 treatment group

Sponsors and collaborators

Barbara Malene Fischer

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution

Danish Cancer Society

Collaborator

Herlev Hospital

Collaborator