TheraSphere® For Treatment of Metastases in Liver

NCT04517643 | Completed Results

• 2 other identifiers: J2006National Institute Of Health
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate whether the dose predicted by pre-therapy 99mTc MAA SPECT predicts the dose to the liver from the 90Y microspheres as assessed by post-therapy 90Y SPECT/CT or positron emission tomography (PET)/CT.

Conditions

Colorectal Cancer Metastatic; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients That Met the Criterion That the Dose Estimated With Tc-99m MAA SPECT Was Within 15% of the Dose Estimated From Y-90 SPECT

  Change in dose estimates of radioactivity from Therasphere treatment to liver tumor target, measured in Gray, will be compared at pre-treatment and up to 6 hours post-treatment. Reported as number of patients that met the criterion that the dose estimated with Tc-99m MAA SPECT was within 15% of the dose estimated from Y-90 SPECT

  Pre-Treatment and up to 6 hours Post-Treatment

Study Arms (1)

Therasphere Therapy

EXPERIMENTAL

All participants will receive the Therasphere Therapy.

Other: Therasphere Therapy

Interventions

Therasphere Therapy OTHER

TheraSphere is a radiotherapy treatment for primary and secondary liver neoplasia. This is an imaging study that will examine 3-5 patients who have been treated for metastatic colorectal cancer in the liver using TheraSphere®. Participation in the study involves an additional post-treatment SPECT/CT or PET/CT scan at (0-6) hours.

Therasphere Therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The Diagnosis of metastatic colorectal cancer to the liver
• Patients with a diagnosis of metastatic colorectal cancer to the liver
• Liver metastases are unresectable
• Tumors are hypervascular based on visual estimation by the Investigator
• Target tumors are measurable using standard imaging techniques
• Performance Status Score 0 - 2
• Age ≥18 years
• Life expectancy ≥3 months
• \>4 weeks since prior radiation, surgery or chemotherapy
• Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
• At least one month has elapsed since most recent prior cancer therapy with the following exception:
• Patient is willing to participate in the study and has signed the study informed consent

You may not qualify if:

• Any pre-treatment laboratory findings within 15 days of treatment demonstrating liver dysfunction:
• Blood test result levels outside of the normal range
• Any history of hepatic encephalopathy
• Any contraindications to angiography and hepatic artery catheterization such as:
• History of severe allergy or intolerance to any contrast media, narcotics, sedatives or atropine that cannot be corrected or premedicated
• Bleeding diathesis, not correctable by usual forms of therapy
• Severe peripheral vascular disease that would preclude catheterization.
• Evidence of pulmonary insufficiency
• Significant extrahepatic disease representing an imminent life-threatening outcome
• Active uncontrolled infection
• Significant underlying medical or psychiatric illness
• Co-morbid disease or condition that would preclude safe delivery of TheraSphere® treatment or, in the judgment of the physician, place the patient at undue risk
• Pregnancy
• Special Categories of Patients: Not applicable
• Research in Mentally Disabled People: No. All participants or legal guardians will be fully able to give informed consent.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Robert Hobbs
• Organization: Johns Hopkins Medicine

rhobbs3@jhmi.edu

410-502-1229

Study Officials

• Robert Hobbs, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To investigate whether the dose predicted by pre-therapy 99mTc MAA SPECT predicts the dose to the liver from the 90Y microspheres as assessed by post-therapy 90Y SPECT/CT or PET/CT.

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 18, 2020
• Study Start: November 12, 2020
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2022
• Last Updated: October 6, 2023
• Results First Posted: October 6, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)