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NCT Number: NCT07342231

FAPi PET in Pancreatic Ductal Adenocarcinoma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tata Memorial Hospital, Mumbai, India

Mumbai, Maharashtra, 400012, India

Location status: Recruiting

Location contact

Ameya Puranik, DNB

PRINCIPAL_INVESTIGATOR

Farkhanda Khan, MSc

CONTACT

[email protected]

Sushil Yadav

CONTACT

[email protected]

912224177000 ext. 7019

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ga-68 FAPi PET/CT

Diagnostic Test

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

Other names: FAPi PET

Primary outcomes

  1. Imaging validation of Ga-68 FAPi PET/CT

    Time frame: 6 and 12 months

    To calculate sensitivity, specificity, positive predictive value and negative predictive value of quantitative and semi-quantitative parameters on FAPi PET

Study contacts

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

Sushil Yadav, MSc

CONTACT

[email protected]

912224177000 ext. 7019

Sponsors and collaborators

Lead sponsor

Tata Memorial Hospital

Other Gov

Registry information

Official study title

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

Acronym: FAP-1

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 15, 2026
Registry last updated
Jan 15, 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.

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