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

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03303469
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arm: 1
• Actual Duration (Months): 38.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: FMISO; Drug: FMISO; Drug: FMISO	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: [18F]Fluoromisonidazole (FMISO) Imaging
• Actual Study Start Date: Oct 30, 2017
• Actual Primary Completion Date: Jan 6, 2021
• Actual Study Completion Date: Jan 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FMISO PET imaging post TACE and Stereotactic body radiation therapy (SBRT) FMISO imaging at baseline, post-TACE and post-SBRT	Drug: FMISO; FMISO PET/CT imaging at baseline; Drug: FMISO; FMISO PET/CT post TACE; Drug: FMISO; FMISO PET/CT post SBRT

Outcome Measures

Primary Outcome Measures

1. Quantitate HCC Tumor Hypoxia at Baseline Using FMISO Positron Emission Tomography (PET). [At baseline]

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

2. Measure Changes in HCC Tumor Hypoxia and Blood Flow After Trans-arterial Chemoembolization (TACE), Prior to Radiotherapy. [1 month post-TACE procedures and prior to SBRT]

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

3. Measure Changes in Treated HCC Tumor Hypoxia Following TACE and Radiotherapy [1 month post-SBRT]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB Advanced Imaging Facility	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Janis P O'Malley, M.D., University of Alabama at Birmingham

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 30, 2020

More Information

Publications

None provided.

• Responsible Party: Janis P. O'Malley, MD, Principal Investigator, Professor of Radiology, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03303469
• Other Study ID Numbers: F170519002
• First Posted: Oct 6, 2017
• Last Update Posted: Feb 21, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular

Study Results

Participant Flow

Arm/Group Title	FMISO PET Imaging Post TACE and SBRT
Arm/Group Description	FMISO imaging at baseline, post-TACE and post-SBRT FMISO: FMISO PET/CT imaging at baseline FMISO: FMISO PET/CT post TACE FMISO: FMISO PET/CT post SBRT
Period Title: Overall Study
STARTED	3
COMPLETED	1
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	FMISO PET Imaging Post TACE and SBRT
Arm/Group Description	FMISO imaging at baseline, post-TACE and post-SBRT FMISO: FMISO PET/CT imaging at baseline FMISO: FMISO PET/CT post TACE FMISO: FMISO PET/CT post SBRT
Overall Participants	3
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 33.3%
>=65 years	2 66.7%
Sex: Female, Male (Count of Participants)
Female	1 33.3%
Male	2 66.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	3 100%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	3 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

We were unable to perform the statistical analysis due to insufficient data collection.

Arm/Group Title	FMISO PET Imaging Post TACE and SBRT
Arm/Group Description	FMISO imaging at baseline, post-TACE and post-SBRT FMISO: FMISO PET/CT imaging at baseline FMISO: FMISO PET/CT post TACE FMISO: FMISO PET/CT post SBRT
Measure Participants	0

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

We were unable to perform the statistical analysis due to insufficient data collection.

Arm/Group Title	FMISO PET Imaging Post TACE and SBRT
Arm/Group Description	FMISO imaging at baseline, post-TACE and post-SBRT FMISO: FMISO PET/CT imaging at baseline FMISO: FMISO PET/CT post TACE FMISO: FMISO PET/CT post SBRT
Measure Participants	0

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

We were unable to perform the statistical analysis due to insufficient data collection.

Arm/Group Title	FMISO PET Imaging Post TACE and SBRT
Arm/Group Description	FMISO imaging at baseline, post-TACE and post-SBRT FMISO: FMISO PET/CT imaging at baseline FMISO: FMISO PET/CT post TACE FMISO: FMISO PET/CT post SBRT
Measure Participants	0

Adverse Events

Time Frame	Between 4 to 6 weeks.
Arm/Group Title	FMISO PET Imaging Post TACE and SBRT
Arm/Group Description	FMISO imaging at baseline, post-TACE and post-SBRT FMISO: FMISO PET/CT imaging at baseline FMISO: FMISO PET/CT post TACE FMISO: FMISO PET/CT post SBRT
All Cause Mortality
	FMISO PET Imaging Post TACE and SBRT
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Serious Adverse Events
	FMISO PET Imaging Post TACE and SBRT
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Other (Not Including Serious) Adverse Events
	FMISO PET Imaging Post TACE and SBRT
	Affected / at Risk (%)	# Events
Total	0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.