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| ID | Type | Description | Link |
|---|---|---|---|
| TRAC/0324/4238/001 | Other Grant/Funding Number | DAE CTC |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with biopsy proven pancreatic ductal adenocarcinoma
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sushil Yadav, MSc | Contact | 912224177000 | 7019 | sushilyadav.crc@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ameya Puranik, DNB | Tata Memorial Hospital, Mumbai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tata Memorial Hospital, Mumbai, India | Recruiting | Mumbai | Maharashtra | 400012 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38727829 | Background | 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. |
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It is against the recommendations of institutional ethics committee
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2024 | Jan 7, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |