Humanitarian Device Exemption (HDE) Treatment Protocol For Treatment of Unresectable Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01176604
Recruitment Status : Recruiting
First Posted : August 6, 2010
Last Update Posted : March 7, 2018
BTG International Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

August 4, 2010
August 6, 2010
March 7, 2018
August 2010
August 2019   (Final data collection date for primary outcome measure)
Overall Survival Associated With TheraSphere Treatment [ Time Frame: 3-6 weeks post treatment ]
Same as current
Complete list of historical versions of study NCT01176604 on Archive Site
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Not Provided
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Humanitarian Device Exemption (HDE) Treatment Protocol For Treatment of Unresectable Hepatocellular Carcinoma
Protocol For Use of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma

This is a Humanitarian Use Device study. A Humanitarian Use Device is a medical device intended to benefit patients in treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals per year in the United States. This consent and authorization form explains why this HUD study is being done and what your role will be if you choose to take part. This form also describes the possible risks connected with being in this study. After reviewing this information with the person responsible for your enrollment, you should know enough to be able to make an informed decision on whether you want to take part in the study. You may choose not to take part in this study

You are being asked to take part in this study because you have liver cancer and are not eligible for surgery. You are being asked to receive humanitarian use device (HUD -- a device used only in patients with rare diseases) treatment at The University of Texas MD Anderson Cancer Center ("MD Anderson").

The goal of this study is to learn more about the patient experience, including any reported side effects and possible benefit related to the use of the TheraSphere device for treatment of liver cancer. Because treatment using the TheraSphere device must be designed specifically for each patient, the treatment process will also be monitored.

The Humanitarian Use Device Program is for FDA approved device that is safe and provides probable benefit.

TheraSphere is a humanitarian use device that is approved by the FDA for the treatment of rare disorders affecting less than 4,000 people in the U.S. each year.

Up to 200 patients will receive the treatment. All will be enrolled at M.D. Anderson.

TheraSphere is a medical device containing yttrium-90 (Y-90), a radioactive material that has been used to treat liver tumors. When Y-90 is put into microscopic glass beads, called microspheres, it can be injected directly into the liver by artery. This allows a large dose of radiation to be delivered directly to the tumor, which lowers the risk of experiencing toxic radiation side effects from the radiation to in other parts of the body, or to healthy liver tissue. The radiation from TheraSphere treatment stays in the body and begins to lose its effect within 12 days, due to physical decay (please refer to the package insert for more information for more information regarding this). The glass microspheres will stay in the body from that point on, but should not cause any health problems.

All visits and procedures related to the TheraSphere treatment will be performed on an outpatient basis. About 2 weeks before the treatment begins, a small tube (catheter) will be inserted into an artery that goes to the liver, usually in the thigh.

TheraSphere Treatment:

TheraSphere (microspheres filled with Y-90 as described above) will be injected into the tumor in the liver through a catheter that you have already had placed into an artery during an earlier procedure.

You will receive at least 1 TheraSphere injection while you are receiving the treatment. If the doctor thinks it is needed, you will have a second injection about 1 month later. The number of TheraSphere injections you will receive will depend on the size and location of the tumors. The injection should take about 5 minutes to complete each time.

After receiving the TheraSphere injection, you will stay at the hospital for several hours so that the staff can check you for possible side effects. If you experience any serious problems or complications after receiving the injection, you may be admitted to the hospital for observation and possible additional treatment.

Length of Treatment:

You will continue to receive the HUD treatment indefinitely.

Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Carcinoma, Hepatocellular
  • Liver Cancer
Device: TheraSphere Treatment
Injection via arterial catheter of TheraSphere microspheres containing yttrium-90 (Y-90) to whole liver, lobar or segmental treatment delivered as a sequence of treatments using approximately 30 - 90 days apart.
TheraSphere Treatment
Injection via arterial catheter of TheraSphere microspheres containing yttrium-90 (Y-90) to whole liver, lobar or segmental treatment delivered as a sequence of treatments using approximately 30 - 90 days apart.
Intervention: Device: TheraSphere Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2020
August 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Diagnosis of unresectable intrahepatic HCC. 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 alphafetoprotein (AFP)^21 and clinical findings. Guidelines from the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) describe in detail the approach and algorithm for diagnosing HCC.
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 1
  3. Life expectancy >/= 3 months
  4. > 4 weeks since prior radiation, surgery or chemotherapy
  5. Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

  1. Any pre-treatment laboratory findings within 15 days of treatment demonstrating liver dysfunction: • AST (Serum Glutamic-Oxalacetic Transaminase - SGOT) or ALT (Serum Glutamic-Pyruvic Transaminase - SGPT) > 5 times Upper Normal Limit (UNL) • Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)
  2. 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.
  3. Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment
  4. Clinical evidence of pulmonary insufficiency
  5. Evidence of any detectable Technetium-99 Macroaggregated Albumin (Tc-99m MAA) flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow.
  6. Complete occlusion of the main portal vein.
  7. Significant extrahepatic disease representing an imminent life-threatening outcome
  8. Active uncontrolled infection.
  9. Significant underlying medical or psychiatric illness.
  10. Co-morbid disease of condition that would preclude safe delivery of TheraSphere treatment or, in the judgment of the physician, place the patient at undue risk
  11. Pregnancy
  12. Tumor type demonstrated on imaging to be infiltrative, tumor volume > 70% of the target liver volume, or tumor nodules too numerous to count, or tumor volume > 50% combined with an albumin < 3 g/dL, or complete occlusion of the main portal vein.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact: Armeen Mahvash, MD 713-563-7340
United States
NCI-2010-01956 ( Registry Identifier: NCI CTRP )
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
BTG International Inc.
Principal Investigator: Armeen Mahvash, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP