Pancreatic CancerFAP-1NCT07342231
FAPi PET in Pancreatic Ductal Adenocarcinoma
An observational study of Pancreatic Cancer and Adenocarcinoma Pancreas, run by Tata Memorial Hospital at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Adenocarcinoma Pancreas
- What is being tested?
- Ga-68 FAPi PET/CT
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 4 Jan 2025to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with biopsy proven pancreatic ductal adenocarcinoma
Who may be able to join
- Any gender with age more than 18 years
- Patients with biopsy-proven pancreatic ductal adenocarcinoma
- Patient willing to participate in study
Who cannot join
- Patient with concurrent malignancy
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Hospital, Mumbai, India
Mumbai, Maharashtra, 400012
Sushil Yadav, 912224177000 ext. 7019, sushilyadav.crc@gmail.com
Farkhanda Khan, MSc, ameya2812@gmail.com
About this study
Official title: FAP-1 Study: FAPi PET in Pancreatic Ductal Adenocarcinoma: A Prospective, Exploratory Study
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.
- Conditions
- Pancreatic Cancer, Adenocarcinoma Pancreas
- Being tested
- Ga-68 FAPi PET/CT
- Keywords
- Fibroblast activation protein, PETCT, FAPi
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga-68 FAPi PET/CTDiagnostic test
Also called FAPi PET
Ga-68 FAPi PET/CT is a whole body scan to assess the FAP receptor expression in patients with pancreatic ductal adenocarcinoma
| Study group | Role | What they receive |
|---|---|---|
| Study Arm 1: Patients who have been diagnosed with pancreatic ductal adenocarcinoma will undergo Ga- | Patients with pancreatic ductal adenocarcinoma who undergo standard work-up with histopathology and conventional imaging will be referred for Ga-68 FAPi PET/CT Receives: Diagnostic Test: Ga-68 FAPi PET/CT | |
| Study Arm 2: Treated patients with pancreatic ductal adenocarcinoma showing rising tumor markers (CA | Patients who undergo surgery or upfront chemotherapy and subsequently have rising tumor marker levels Receives: Diagnostic Test: Ga-68 FAPi PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging validation of Ga-68 FAPi PET/CT
To calculate sensitivity, specificity, positive predictive value and negative predictive value of quantitative and semi-quantitative parameters on FAPi PET
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start4 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ameya Puranik, Tata Memorial Hospital
- Investigators
- Ameya Puranik, DNB, Principal investigator, Tata Memorial Hospital, Mumbai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342231
- Sponsor's protocol ID
- TMCIEC4238
- Other IDs
- TRAC/0324/4238/001
- Acronym
- FAP-1
- Status last verified
- Jan 2026
- First submitted
- 19 Nov 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is against the recommendations of institutional ethics committee
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.
PubMed 38727829
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAP-1 Study: FAPi PET in Pancreatic Ductal Adenocarcinoma: A Prospective, Exploratory Study
- ClinicalTrials.gov ID
- NCT07342231
- Acronym / sponsor ID
- FAP-1 / TMCIEC4238
- Conditions
- Pancreatic Cancer, Adenocarcinoma Pancreas
- Keywords
- Fibroblast activation protein, PETCT, FAPi
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- 4 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Arm 1: Patients who have been diagnosed with pancreatic ductal adenocarcinoma will undergo Ga- | – | Diagnostic Test: Ga-68 FAPi PET/CTPatients with pancreatic ductal adenocarcinoma who undergo standard work-up with histopathology and conventional imaging will be referred for Ga-68 FAPi PET/CT |
| Study Arm 2: Treated patients with pancreatic ductal adenocarcinoma showing rising tumor markers (CA | – | Diagnostic Test: Ga-68 FAPi PET/CTPatients who undergo surgery or upfront chemotherapy and subsequently have rising tumor marker levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with biopsy proven pancreatic ductal adenocarcinoma
Key inclusion criteria (3 listed)
- Any gender with age more than 18 years
- Patients with biopsy-proven pancreatic ductal adenocarcinoma
- Patient willing to participate in study
Key exclusion criteria (2 listed)
- Patient with concurrent malignancy
- Pregnancy and lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ga-68 FAPi PET/CTAlso: FAPi PETGa-68 FAPi PET/CT is a whole body scan to assess the FAP receptor expression in patients with pancreatic ductal adenocarcinoma | Diagnostic test | Study Arm 1: Patients who have been diagnosed with pancreatic ductal adenocarcinoma will undergo Ga-, Study Arm 2: Treated patients with pancreatic ductal adenocarcinoma showing rising tumor markers (CA |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Background: PubMed 38727829Yuan 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.
- Individual participant dataSharing planned: No. It is against the recommendations of institutional ethics committee
Related trials for Pancreatic Cancer
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Oesophageal Cancer, Gastric Cancer
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RecruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ameya Puranik, DNB principal investigator
Tata Memorial Hospital, Mumbai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Adenocarcinoma Pancreas, run by Tata Memorial Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sushil Yadav, MSc (912224177000 ext. 7019, sushilyadav.crc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging validation of Ga-68 FAPi PET/CT (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07342231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.