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A Study of Selective Internal Radiation Therapy for the Management of Chemotherapy-induced Thrombocytopenia With Splenomegaly in Adult Subjects With Gastrointestinal Cancer

NCT07575854 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-13

No results posted yet for this study

Summary

This is a prospective, interventional, open-label, single-arm, multicenter pilot study evaluating the safety, tolerability and maximum tolerated dose (MTD) of splenic Selective Internal Radiation Therapy (SIRT) using TheraSphere in adult patietns with gastrointestinal cancer and chemotherapy-induced thrombocytopenia with splenomegaly

Conditions

Interventions

DEVICE

TheraSphere

Patients will receive a single administration of Yttrium-90 glass microspheres (TheraSphere) delivered via selective catheterization of the splenic artery as part of a Selective Internal Radiation Therapy (SIRT) procedure. The treatment is performed by interventional radiology using a femoral or brachial arterial approach, followed by intra-arterial infusion of the microsphere through a microcatheter positioned in the splenic arterial branches. A dose-escalation scheme is applied with three planned absorbed dose levels (100Gy, 150 Gy and 200 Gy) to determine the maximum tolerated dose (MTD). The administrated activity is calculated based on splenic volume and vascular anatomy assessed during pre-treatment imaging. TheraSphere is administered once on Day 1, with no repeat dosing. Patients undergo post-procedural imaging and are followed for safety, efficacy and dosimetry outcomes.

Sponsors & Collaborators

  • Centre Georges Francois Leclerc

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2026-12-01
Completion
2029-04-01

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07575854 on ClinicalTrials.gov