Integrated Imaging Strategy to Phenotype Progression of Liver Tumors During and After Chemoembolization

NCT02471313 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: 150137NCT0247131315-CC-0137
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Treatment for liver cancer can include surgery, transplant, and chemotherapy. It can also include other minimally invasive tumor treatments such as transarterial chemoembolization (TACE). TACE treatment for liver cancer helps control the cancer but is not considered a cure. Researchers want to learn more about the effects of TACE on liver tumors and surrounding tissue. To do this, they will use a positive emission test (PET) and a radioactive tracer called \[18F\] FMISO. Objectives: \- To see if \[18F\] FMISO is useful for evaluating what happens to liver tumors and surrounding tissue after TACE. Eligibility: \- People age 18 and older with liver cancer who have been approved to have TACE. Design:

• Participants will meet with a study researcher to see if they can take part in the study.
• Participants will have TACE under a separate NCI protocol or at a hospital other than the NIH Clinical Center.
• Before and after TACE, participants will have a CT and MRI of the abdomen. For these scans, they will lie in a machine that takes pictures of their body. They will also have blood tests and a physical exam.
• The \[18F\] FMISO imaging study will be performed at NIH only.
• Participants will have an intravenous catheter placed in their arm (if they do not have one). The \[18F\] FMISO tracer will be injected.
• Participants will have PET-CT scans. Each scan will take about 30 minutes.
• Some participants will also have \[18F\] FMISO and PET-CT scans before TACE.
• As part of standard care for TACE, participants will have CT and MRI scans at regular intervals. This will evaluate tumor response.

Conditions

Liver Cancer; Liver Neoplasm; Hepatocellular Carcinoma; HCC

Keywords

Cross-Sectional Imaging; Chemoembolization; Radiation Therapy; Tumor Hypoxia; PET Imaging

Outcome Measures

Primary Outcomes (1)

• Number of Participants for Which Uptake of [18F]-FMISO Was Successful and Hypoxic Tumors Were Observed During PET Scan Imaging Post TACE Procedure

  A single dose of study imaging agent \[18F\] FMISO was administered following the TACE procedure. PET Scan imaging was then performed to evaluate if hypoxic tumor identification were observable following administration of study imaging agent. Power and significance calculations are not applicable to this small sample feasibility study.

  up to 72 hours after injection of [18F] FMISO

Study Arms (1)

[18F] FMISO PET scan

EXPERIMENTAL

Patients with primary hepatic malignancy who underwent \[18F\] FMISO PET Scan following transarterial chemoembolization (TACE) procedure

Drug: [18F] FMISO

Interventions

[18F] FMISO DRUG

\[18F\] Fluromisonidazole, 1 h-(3-\[18F\]-fluro-2hydroxyl-propy10-2-nitro-imidazaole is an investigational positron emission tomography (PET) radiopharmaceutical for injection and used to visualize hypoxia imaging agent. Each patient will receive up to 10 mCi of \[18F\] FMISO PET imaging post TACE procedure.

Also known as: FMISO

[18F] FMISO PET scan

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have confirmed inoperable primary hepatic malignancy or hepatic dominant metastatic - neoplastic disease evidenced by histology or cytology, or characteristic enhancement pattern on CT or MRI together with an abnormal serum alpha-fetoprotein \>200mg/dl in the case of hepatocellular carcinoma.
• Patients with hepatocellular carcinoma should conform to intermediate stage disease according to the BCLC(16) staging system (Stage A4 or B) and be otherwise eligible to receive TACE treatment.
• Patients must have had no chemotherapy or radiotherapy to the liver therapy for, their malignancy for at least 2 weeks (or until response can be adequately assessed) prior to treatment and must have recovered from all clinically significant side effects of therapeutic and diagnostic interventions.
• Serum creatinine less than or equal to 2.0 mg/dl unless the measured creatinine clearance is greater than 60ml/min
• Age greater than or equal to18 years
• Ability of subject to understand and willingness to sign a written informed consent document
• Patient must be able to lie still for the procedure
• ECOG status less than or equal to 2
• In addition, for patients receiving TACE outside NIH:
• Patient must have physician willing to collaborate with NIH PI by providing required medical record and digital MR/ CT scan documentation pre and post TACE procedure.
• Patient must be willing to sign an Authorization for the Release of Medical Information form

You may not qualify if:

• Patients who have received prior TACE treatment
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to misonidazole or other agents used in study.
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients of childbearing age must not be pregnant. The effects of \[(18)F\]FMISO on the developing human fetus are unknown. Pregnancy is a contraindication for TACE.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• THOMLINSON RH, GRAY LH. The histological structure of some human lung cancers and the possible implications for radiotherapy. Br J Cancer. 1955 Dec;9(4):539-49. doi: 10.1038/bjc.1955.55. No abstract available.

  PMID: 13304213 BACKGROUND

• Vaupel P, Mayer A, Hockel M. Tumor hypoxia and malignant progression. Methods Enzymol. 2004;381:335-54. doi: 10.1016/S0076-6879(04)81023-1. No abstract available.

  PMID: 15063685 BACKGROUND

• Durand RE, Aquino-Parsons C. Non-constant tumour blood flow--implications for therapy. Acta Oncol. 2001;40(7):862-9. doi: 10.1080/02841860152703508.

  PMID: 11859987 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

fluoromisonidazole

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Elliot Levy, Staff Clinician, Radiology & Imaging Sciences
• Organization: National Institutes of Health Clinical Center

levyeb@cc.nih.gov

301-402-5368

Study Officials

• Elliot B Levy, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 15, 2015
• Study Start: June 12, 2015
• Primary Completion: March 7, 2018
• Study Completion: March 7, 2018
• Last Updated: April 23, 2019
• Results First Posted: April 23, 2019

Record last verified: 2018-03-07

Locations

US (1)