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Selective Intra-Arterial Radionuclide Therapy of Liver Cancer using Lu-177 and Ho-166

Exploring Pre-developed Microspheres for Radiolabeling with Indigenous Beta Emitting Radionuclides of Varying Energy for Selective Intra-Arterial Radionuclide Therapy of Liver Cancer: A Step Towards Self-Sustainability - Lu-177 SIRT

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/053177
Enrollment
100
Registered
2023-05-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: D015- Carcinoma in situ of liver, gallbladder and bile ducts

Interventions

Intervention1: Radiolabelled microspheres: Indegenously prepared Microspheres radiolabelled with beta emitting therapeutic radionuclides produced within our country (BARC INDIA) will be used be used.

Sponsors

Departmental project
Lead Sponsor
Department of Nuclear Medicine initiated project
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: · Patients older than 18 years of age · Confirmed diagnosis of HCC with no previous specific treatment · Has at least one measurable (one-dimensional) tumor >5cm · Patients with or without portal vein thrombosis · Have acceptable biological test reports · 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 liver function (Child score C) · Extra-hepatic metastasis · Severe chronic pulmonary disease · 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 appearance of necrosis with in the treated lesion as per modified response evaluation criteria. 2. Reduction in elevated liver enzymes 3. Decreased level of AFP (if raised) Timepoint: 8-12 weeks post procedure

Secondary

MeasureTime frame
improved quality of life study survival benefitTimepoint: every 6 month followup

Countries

India

Contacts

Public ContactDr Jaya Shukla

Post Graduate Institute of Medical Education and Research

shuklajaya@gmail.com9781533400

Outcome results

None listed

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