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BOLD MRI and FMISO PET for the Assessment of Hypoxic Tumor Microenvironment in Patients With Oligometastatic Liver Cancer Undergoing Yttirum-90 Selective Internal Radiation Therapy

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ClinicalTrials.gov Identifier: NCT05250895
Recruitment Status : Recruiting
First Posted : February 22, 2022
Last Update Posted : May 2, 2024
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Brandon, Emory University

Study Description
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Brief Summary:
This early phase I trial evaluates the use of hypoxia (lack of oxygen) as a measure in determining the outcome of Y90 selective internal radiation therapy in patients with liver cancer that has spread to a limited number of sites (oligometastatic). Radioembolization with Y90 is a minimally invasive procedure that combines embolization and radiation therapy to treat metastatic liver cancer. Tiny beads filled with radioactive isotope Y-90 are placed inside the blood vessel that provide blood supply to the tumor. This will block the blood flow to the tumor cells while providing a high radiation dose without harming healthy normal tissue.

Condition or disease Intervention/treatment Phase
BCLC Stage A Hepatocellular Carcinoma BCLC Stage B Hepatocellular Carcinoma BCLC Stage C Hepatocellular Carcinoma Hepatocellular Carcinoma Other: 18F-Fluoromisonidazole Procedure: Biopsy Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging Procedure: Positron Emission Tomography Early Phase 1

Detailed Description:

PRIMARY OBJECTIVE:

I. To investigate the variability of hypoxia in hepatocellular carcinoma (HCC) as quantified by blood oxygen level-dependent (BOLD) magnetic resonance imaging (MRI) and dynamic 18F-Fluoromisonidazole (FMISO) positron emission tomography (PET).

SECONDARY OBJECTIVES:

I. Investigate whether hypoxia, as quantified by BOLD MRI, dynamic FMISO PET, HIF-1alpha and VEGF expression, predicts HCC response to yttrium-90 (Y90) selective internal radiation therapy (SIRT).

II. Assess whether hypoxia quantification by BOLD MRI, dynamic FMISO, HIF-1alpha or VEGF expression individually or in combination more accurately predict the degree of HCC tumor response to Y90 SIRT.

III. Compare the tumor dose response threshold between hypoxic and non-hypoxic HCCs treated with Y90 SIRT.

OUTLINE:

Patients receive 18F-fluoromisonidazole intravenously (IV) and undergo PET and dynamic contrast enhanced (DCE) MRI within 30 days before beginning Y90 SIRT. Patients undergo Y90 SIRT per standard of care.

After completion of study intervention, patients are followed up at 90 days, and then every 12 weeks thereafter.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Molecular Imaging of the Hypoxic Tumor Microenvironment to Predict Response to Yttirum-90 Selective Internal Radiation Therapy in Hepatocellular Carcinoma- Pilot Study
Actual Study Start Date : April 28, 2022
Estimated Primary Completion Date : January 30, 2025
Estimated Study Completion Date : January 30, 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Diagnostic (18F-fluoromisonidazole, PET, DCE MRI)
Patients receive 18F-fluoromisonidazole IV and undergo PET and DCE MRI within 30 days before beginning Y90 SIRT. Patients undergo Y90 SIRT per standard of care.
 Other: 18F-Fluoromisonidazole
Given IV
Other Names:
  • 18F-MISO
  • 18F-Misonidazole
  • FMISO

Procedure: Biopsy
Undergo biopsy
Other Names:
  • BIOPSY_TYPE
  • Bx

Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo DCE MRI
Other Names:
  • DCE
  • DCE MRI
  • DCE-MRI
  • DYNAMIC CONTRAST ENHANCED MRI

Procedure: Positron Emission Tomography
Undergo PET
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging


Outcome Measures
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Primary Outcome Measures :
  1. To investigate the variability of hypoxia in HCC at baseline as quantified by BOLD MRI [ Time Frame: From weeks 1-2 up to 1 year ]
    Threshold <1.0 R2 tumor to normal ratio (no unit) as a cutoff for hypoxia

  2. To investigate the variability of hypoxia in HCC at baseline as quantified by immunohistochemistry [ Time Frame: From weeks 1-2 up to 1 year ]
    The staining intensity will be measured and scored with four scales: no staining=0, weak staining=1, moderate staining=2, and strong staining=3. The final staining score will be obtained by stained stumor area% x positive tumor cells % x staining intensity. The tumors will be then categorized as hypoxic (scores 8 to 16) vs. non-hypoxic (scores 0 to 7) (no units).


Secondary Outcome Measures :
  1. Determine whether hypoxia is predictor of response in HCC treated with Y90 SIRT [ Time Frame: From week 0 up to 1 year ]
    Treatment Response Assessment using mRECIST

  2. Treatment response [ Time Frame: From week 0 Up to 1 year ]
    Assessed using modified Response Evaluation Criteria in Solid Tumors.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >= 18 years
  • Established HCC diagnosis, unilobar or bilobar disease
  • At least 1 tumor >= 3 cm
  • Oligometastatic disease
  • Barcelona Clinic Liver Cancer (BCLC) stage A, B or C
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • Life expectancy > 12 weeks as determined by the Investigator
  • The effects of Y90 Radioembolization on the developing human fetus are unknown. For this reason, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
  • FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months

Exclusion Criteria:

  • Patients who are definite transplant candidates
  • Concurrent second malignancy outside of the liver
  • Infiltrative liver tumor
  • Previous liver-directed therapy to targeted tumors
  • BCLC stage D
  • Bilirubin > 2 mg/dL for lobar treatment and bilirubin > 3 mg/dL for segmental or bi-segmental Y90-SIRT
  • Albumin < 3 g/dL
  • Projected lung dose of > 30 Gy in a single session to the liver after prospective treatment planning
  • Body mass index (BMI) > 40
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05250895


Contacts
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Contact: Nima Kokabi, MD, FRCPC (404) 778-4747 nkokabi@emory.edu
Contact: David Schuster, MD 404-712-4859 dschust@emory.edu

Locations
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United States, Georgia
Emory University Hospital/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Maria Rivas    404-712-7962    mrivas2@emory.edu   
Principal Investigator: Nima Kokabi, MD, FRCPC         
Sponsors and Collaborators
Emory University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Nima Kokabi, MD, FRCPC Emory University
More Information
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Responsible Party: David Brandon, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT05250895    
Other Study ID Numbers: STUDY00002804
NCI-2021-09943 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
STUDY00002804
RAD5342-21 ( Other Identifier: Emory University Hospital/Winship Cancer Institute )
P30CA138292 ( U.S. NIH Grant/Contract )
First Posted: February 22, 2022    Key Record Dates
Last Update Posted: May 2, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Liver Diseases
Misonidazole
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents