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FAPi PET in Pancreatic Ductal Adenocarcinoma

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07342231
Acronym
FAP-1
Enrollment
60
Registered
2026-01-15
Start date
2025-01-04
Completion date
2027-01-01
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma Pancreas, Pancreatic Cancer

Keywords

Fibroblast activation protein, PETCT, FAPi

Brief summary

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_TESTGa-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

Sponsors

Tata Memorial Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Imaging validation of Ga-68 FAPi PET/CT6 and 12 monthsTo calculate sensitivity, specificity, positive predictive value and negative predictive value of quantitative and semi-quantitative parameters on FAPi PET

Countries

India

Contacts

Primary ContactSushil Yadav, MSc
sushilyadav.crc@gmail.com912224177000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026