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Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: Fluorine18 (18F) Fluoromisonidazole (FMISO) Imaging

Primary Purpose

Hepatocellular Carcinoma

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

FMISO

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult (> 18 years of age) patients with documented HCC tumor mass >3cm, who are scheduled to undergo TACE with additional selective internal radiation therapy (SIRT)
The appropriate criteria for inclusion for this patient population are:
Biopsy or radiological diagnosis of HCC (defined as Organ Procurement and Transplantation Network (OPTN*) Category 5 lesion either on CT or MRI)
Scheduled for TACE (using doxorubicin-eluting beads) + SBRT
Willingness to undergo PET/CT
Able to lie on the imaging table for up to 1 hour.
Able to provide signed informed consent.
Women with childbearing potential must have a negative urine Beta-Human Chorionic Gonadotropin (β-hCG) test day of procedure

Exclusion Criteria:

Estimated life expectancy <12 months or serious medical co-morbidities that would preclude definitive local therapy
Unable to lie on the imaging table
Age less than 18 years.
Pregnancy or lactation
Inability or unwillingness to provide informed consent.
Weight >500 lbs (the weight limit of the tomograph gantry table)

Sites / Locations

UAB Advanced Imaging Facility

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FMISO PET imaging post TACE and Stereotactic body radiation therapy (SBRT)

Arm Description

FMISO imaging at baseline, post-TACE and post-SBRT

Outcomes

Primary Outcome Measures

Quantitate HCC Tumor Hypoxia at Baseline Using FMISO Positron Emission Tomography (PET).

Perform PET/CT imaging using FMISO at baseline to measure tumor hypoxia

Measure Changes in HCC Tumor Hypoxia and Blood Flow After Trans-arterial Chemoembolization (TACE), Prior to Radiotherapy.

Perform PET/CT imaging using FMISO post-TACE and prior to Stereotactic body radiation therapy (SBRT) to determine tumor hypoxia

Measure Changes in Treated HCC Tumor Hypoxia Following TACE and Radiotherapy

Perform PET/CT imaging using FMISO post-SBRT to determine tumor hypoxia

Secondary Outcome Measures

Full Information

NCT ID

NCT03303469

First Posted

September 13, 2017

Last Updated

February 15, 2021

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT03303469

Brief Title

Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: Fluorine18 (18F) Fluoromisonidazole (FMISO) Imaging

Official Title

Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: [18F]Fluoromisonidazole (FMISO) Imaging

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Terminated

Why Stopped

study was terminated due to poor enrollment

Study Start Date

October 30, 2017 (Actual)

Primary Completion Date

January 6, 2021 (Actual)

Study Completion Date

January 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

[18F] FMISO Positron Emission Tomography (PET) to determine hypoxia in patients with HCC treated with TACE.

Detailed Description

This Phase II study will investigate the utility of [18F] FMISO in patients with hepatocellular carcinoma (HCC). This trial is designed to test the hypothesis that PET determined [18F]FMISO uptake will indicate tumor hypoxia in patients with HCC treated with trans-arterial chemo-embolization (TACE). We anticipate that [18F] FMISO PET/CT will advance our understanding of the role of hypoxia in HCC prior to treatment and that this knowledge will help design newer combination therapeutic trials for better treatment outcomes. [18F] FMISO PET/CT provides three parameters, tissue hypoxic volume (HV), maximum tissue to blood uptake ratio (T:Bmax) and tumor blood flow. Both pre-and post-therapy images will be examined to investigate changes in these parameters during the course of TACE treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FMISO PET imaging post TACE and Stereotactic body radiation therapy (SBRT)

Arm Type

Experimental

Arm Description

FMISO imaging at baseline, post-TACE and post-SBRT

Intervention Type

Drug

Intervention Name(s)

FMISO

Intervention Description

FMISO PET/CT imaging at baseline

Intervention Type

Drug

Intervention Name(s)

FMISO

Intervention Description

FMISO PET/CT post TACE

Intervention Type

Drug

Intervention Name(s)

FMISO

Intervention Description

FMISO PET/CT post SBRT

Primary Outcome Measure Information:

Title

Quantitate HCC Tumor Hypoxia at Baseline Using FMISO Positron Emission Tomography (PET).

Description

Perform PET/CT imaging using FMISO at baseline to measure tumor hypoxia

Time Frame

At baseline

Title

Measure Changes in HCC Tumor Hypoxia and Blood Flow After Trans-arterial Chemoembolization (TACE), Prior to Radiotherapy.

Description

Perform PET/CT imaging using FMISO post-TACE and prior to Stereotactic body radiation therapy (SBRT) to determine tumor hypoxia

Time Frame

1 month post-TACE procedures and prior to SBRT

Title

Measure Changes in Treated HCC Tumor Hypoxia Following TACE and Radiotherapy

Description

Perform PET/CT imaging using FMISO post-SBRT to determine tumor hypoxia

Time Frame

1 month post-SBRT

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult (> 18 years of age) patients with documented HCC tumor mass >3cm, who are scheduled to undergo TACE with additional selective internal radiation therapy (SIRT) The appropriate criteria for inclusion for this patient population are: Biopsy or radiological diagnosis of HCC (defined as Organ Procurement and Transplantation Network (OPTN*) Category 5 lesion either on CT or MRI) Scheduled for TACE (using doxorubicin-eluting beads) + SBRT Willingness to undergo PET/CT Able to lie on the imaging table for up to 1 hour. Able to provide signed informed consent. Women with childbearing potential must have a negative urine Beta-Human Chorionic Gonadotropin (β-hCG) test day of procedure Exclusion Criteria: Estimated life expectancy <12 months or serious medical co-morbidities that would preclude definitive local therapy Unable to lie on the imaging table Age less than 18 years. Pregnancy or lactation Inability or unwillingness to provide informed consent. Weight >500 lbs (the weight limit of the tomograph gantry table)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janis P O'Malley, M.D.

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

UAB Advanced Imaging Facility

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: Fluorine18 (18F) Fluoromisonidazole (FMISO) Imaging

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