HDE Use Protocol of TheraSphere for Treatment of Unresectable HCC

NCT00605150 | Completed Results DMC

• 1 other identifier: HDE# 980006
• Study Type: observational
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief Summary

MDS Nordion's TheraSphere, Yttrium-90 glass microspheres has been approved as a Humanitarian device authorized by federal(USA)law for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma(HCC)who can have placement of appropriately positioned hepatic arterial catheters. Outcomes of this treatment protocol will be monitored and reported to the Carolinas HealthCare System Institutional Review Board.

Conditions

Hepatocellular Carcinoma

Keywords

Unresectable HCC

Outcome Measures

Primary Outcomes (1)

• Progression

  Progression of liver cancer

  6 months

Secondary Outcomes (1)

• Number of Participants With Unacceptable Side Effects After Treatment

  6 months

Study Arms (1)

Patients enrolled

Total number of patients enrolled

Radiation: TheraSphere-Yttrium 90 microsphere

Interventions

TheraSphere-Yttrium 90 microsphere RADIATION

TheraSphere is delivered to the liver via a catheter placed into the femoral artery and guided by fluoroscopy to the hepatic artery. Once the catheter is properly positioned, the physician infuses TheraSphere, which localizes preferentially in the tumor.

Patients enrolled

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will be selected from the population of patients with unresectable cancer in the liver who are referred by surgeons and medical oncologists of CarolinasHealthCare System and by other referring physicians in the geographic area for regional therapy for liver cancer. Patients to be considered for treatment under this protocol will have been referred to one of the clinicians.

You may qualify if:

• Confirmed diagnosis of intrahepatic carcinoma. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha feta protein (AFP) markers (clinical diagnosis).
• The cancer must be unresectable.
• Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0-2
• Age greater than or equal to 18
• Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines.

You may not qualify if:

• Any pre-treatment lab findings within 15 days of treatment demonstrating: absolute granulocyte count less than or equal to 1,500/ul, platelet count less than or equal to 45,000/ul, serum creatinine greater than or equal to 3.0 mg/dl, serum bilirubin greater than or equal to 4.0 mg/dl
• Any of the following contraindications to angiography and selective visceral catheterization: history of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine; bleeding diathesis, not correctable by usual forms of therapy; severe peripheral vascular disease that would preclude catheterization
• Portal hypertension with portal venous shunt away from the liver
• Evidence of potential delivery of greater than 16.5 milliCurie (mCi) or 30 gray (Gy) absorbed dose of radiation to the lungs on either 1) first TheraSphere administration or 2) cumulative delivery of radiation to the lungs \> 30 Gy over multiple treatments.
• Evidence of any detectable Tc-99m microaggregate albumin (MAA) flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow.
• Significant extrahepatic disease representing an imminent life-threatening outcome
• Severe liver dysfunction or pulmonary insufficiency
• Active uncontrolled infection
• Significant underlying medical or psychiatric illness.
• Pregnant women may not participate.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: David Iannitti, MD
• Organization: Carolinas Healthcare System

jessica.drummond@carolinashealthcare.org

704-446-4838

Study Officials

• David A Iannitti, MD

  Carolinas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2008
• First Posted: January 30, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 22, 2022
• Results First Posted: February 16, 2015

Record last verified: 2019-04