Health Condition 1: C253- Malignant neoplasm of pancreatic duct
Conditions
Interventions
Intervention1: PSMA ( 68Ga and 177Lu):
: 68 Ga- PSMA- for imaging
177 Lu-PSMA for dosimetry and therapy
68Ga PSMA for imaging - 5mCi- given Intravenously, and scan acquired after 45 mins- 1 hour.
17
injected intravenously, and imaging acquired after 1 hour ( prevoid), 4 hours, 24 hours, 48 hours and 72 hours.
177Lu PSMA for therapy- 100- 200 mCi- intravenously- every 2 months.
Control Interventi
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: Aged 18 years or above and providing written informed consent. Histological confirmation of the pancreatic ductal adenocarcinoma. Advanced-stage disease who are inoperable and progressive disease after standard-of-care treatments Life expectancy greater than 12 weeks Patients willing to undergo serial whole-body scans and provide blood and urine sample for dosimetry analysis
Exclusion criteria
Exclusion criteria: Eastern Cooperative Oncology Group (ECOG) performance status more than 3. Uncontrolled intercurrent illness. Pregnant and/or lactating women. Refusal to give written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the PSMA expression in advanced/ heavily pretreated pancreatic adenocarcinoma using 68Ga-PSMA-11 PET CT.Timepoint: 0-12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To assess the tumor retention of PSMA-based therapeutic radiopharmaceutical (177Lu-PSMA-617) with low-dose scans ( whole body and SPECT CT) ( 2) To administer the 177Lu-PSMA-617 at therapeutic doses and evaluate the safety and efficacy of the therapy in the study population by assessing the toxicity profile and quality of life (QOL), progression-free survival (PFS) and Overall Survival (OS) after treatment.Timepoint: 12-24 months | — |
Countries
India
Contacts
Public ContactDr Nishikant Avinash Damle
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed