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Novel internal radiation therapy

Radiolabeled fibroblast activation peptide inhibitors (FAPI) as a theranostic molecule in patients with carcinoma of epithelial origin - RNT (Radionuclide therapy)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/057096
Enrollment
50
Registered
2023-08-30
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: C740- Malignant neoplasm of cortex of adrenal gland Health Condition 2: C23- Malignant neoplasm of gallbladder Health Condition 3: C508- Malignant neoplasm of overlappingsites of breast Health Condition 4: C569- Malignant neoplasm of unspecifiedovary Health Condition 5: C787- Secondary malignant neoplasm of liver and intrahepatic bile duct

Interventions

Intervention1: Intravenous injection: Diagnostic radiopharmaceutical Ga-68 FAPI (2-3 mCi) pre therapy for disease spread and uptake information. Ga-68 FAPI PET/CT is also done after every 2 cycles of

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: . Patients older than 18 years of age · Confirmed diagnosis: type of carcinoma . Chemo refractory, multiple lesions or unresectable single lesion . Good uptake on diagnostic Ga-68 FAPI PET/CT · Patients In good general condition (Karnofsky performance status of more than 70) · Ready to give written informed consent for the protocol approved by IEC

Exclusion criteria

Exclusion criteria: · Pregnancy or lactation · Poor kidney function · Any other serious illness · An overall survival expectancy of less than 1 month

Design outcomes

Primary

MeasureTime frame
1. Response in the form of tumor size reduction or disappearance of necrosis within the lesion as per PERSIST criteria 2. Reduction in elevated enzymes/ hormones related to tumor type 3. Improved quality of lifeTimepoint: 6-8 weeks post therapy

Secondary

MeasureTime frame
1. Improved quality of life 2. Study survival benefit 3. study Progression free survival/recurrenceTimepoint: follow up in every 6 month

Countries

India

Contacts

Public ContactDr B R Mittal

Post Graduate Institute of Medical Education and Research

shuklajaya@gmail.com911722756724

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026