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Recruiting NCT07342231

FAPi PET in Pancreatic Ductal Adenocarcinoma

Observational Pancreatic Cancer Adenocarcinoma Pancreas

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: Ga-68 FAPi PET/CT.
Who it may be relevant to
Registry conditions: Pancreatic Cancer, Adenocarcinoma Pancreas. 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
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

FAP-1 Study: FAPi PET in Pancreatic Ductal Adenocarcinoma: A Prospective, Exploratory Study

Overview

Pancreatic adenocarcinoma commonly referred to as pancreatic cancer is a cancer which is known to involve the pancreas and the surrounding structures like blood vessels, which makes it an aggressive cancer. Treatment of the cancer is decided by how much the disease has spread. It has been understood from recent studies that there are some components of the tumor which are not detected by standard CT scan. The tissue in the tumor microenvironment leads to further spread of tumor. The tissue which is seen near the tumor has many attachments on the surface which are currently being studied. One of the most common attachments is Fibroblast activation protein (FAP), which is seen on the surface of tumor tissue. A radioactive tracer Gallium-68 is attached to a small protein known as 'peptide' named 'FAP inhibitor (FAPi)' which shall bind to FAP. Then a PET scan will be performed which shall help in understanding how much of the tissue is seen on the scan in addition to the pancreatic tumor. The investigators shall assess whether the radiotracer (Gallium-68 labeled FAPi) binds to other sites like liver or other organs where the cancer is likely to spread. From the study, the investigators shall study whether the new scanning technique is beneficial as compared to the standard CT scanning. Hence, the investigators would perform Gallium-68-labeled FAPi PET scan in addition to the standard CT scan and compare the results.

Interventions

  • Diagnostic test Ga-68 FAPi PET/CT
    Ga-68 FAPi PET/CT is a whole body scan to assess the FAP receptor expression in patients with pancreatic ductal adenocarcinoma

Primary outcome measures

  • Imaging validation of Ga-68 FAPi PET/CT [Time frame: 6 and 12 months]

Eligibility criteria

Inclusion criteria

  • Any gender with age more than 18 years
  • Patients with biopsy-proven pancreatic ductal adenocarcinoma
  • Patient willing to participate in study

Exclusion criteria

  • Patient with concurrent malignancy
  • Pregnancy and lactation

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

Healthy volunteers: No

Study design

Observational model
Other

Study locations

India · 1 center
  • Tata Memorial Hospital, Mumbai, India — Mumbai

Publications

  • Yuan H, Liu E, Zhang G, Lai C, Zhang Q, Shang Y, Cheng Z, Jiang L. Diagnostic efficacy of [68Ga]Ga-DOTA-GPFAPI-04 in patients with solid tumors in a head-to-head comparison with [18F]F-FDG: results from a prospective clinical study. Eur J Nucl Med Mol Imaging. 2024 Sep;51(11):3360-3372. doi: 10.1007/s00259-024-06756-0. Epub 2024 May 10. PMID 38727829

Identifiers

NCT: NCT07342231 · TMCIEC4238 · TRAC/0324/4238/001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗