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Recruiting NCT07629609

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

Phase II Interventional Pancreatic Cancer, Adult Gastroesophageal Cancer (GC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [68Ga]Ga-FAPI-46.
Who it may be relevant to
Registry conditions: Pancreatic Cancer, Adult, Gastroesophageal Cancer (GC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Denmark · 1 center
  • Rigshospitalet — Copenhagen

Identifiers

NCT: NCT07629609 · 523_22 · 2023-503632-41-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗