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Monitoring Early Response to Targeted Therapy in Stage IV HER2+ Breast Cancer Patients With Advanced PET/MR Imaging

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.
 
ClinicalTrials.gov Identifier: NCT04273555
Recruitment Status : Recruiting
First Posted : February 18, 2020
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
Anna G. Sorace, University of Alabama at Birmingham

Study Description
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Brief Summary:
The purpose of the study is to see if a new group of imaging tests can help identify response to stage IV HER2+ breast cancer before treatment.

Condition or disease Intervention/treatment Phase
HER2-positive Breast Cancer Drug: [18F]-FDG Phase 1 Phase 2

Detailed Description:
The purpose of this study is to see if a new group of imaging tests can help identify response to stage IV human epidermal growth factor receptor 2 positive (HER2+) breast cancer before and during treatment. This study will test a new method for monitoring treatment. The investigators will use [18F]-Fluorodeoxyglucose (FDG) positron emission tomography (PET)/magnetic resonance imaging (MRI) to look at previously diagnosed stage IV breast cancer and image up to three times during therapy. FDG is a non-natural amino acid with a radioactive tag that is used clinically for staging of disease. However, the role of FDG-PET/MRI for imaging response in breast cancer is not currently clear. PET/MRI is a new imaging technique that combines PET and MRI into a single study.
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: Monitoring Early Response to Targeted Therapy in Stage IV Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Cancer Patients With Advanced Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI)
Estimated Study Start Date : January 1, 2023
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: [18F]-Fluorodeoxyglucose (FDG) PET/ MRI Drug: [18F]-FDG
[18F]-FDG will be injected prior to PET/MRI imaging up to three times over the course of six months.


Outcome Measures
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Primary Outcome Measures :
  1. Baseline measure of PET standardized uptake value (SUV). [ Time Frame: Baseline imaging visit 1 ]
    Compare baseline metrics from PET/MRI

  2. Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI. [ Time Frame: Baseline imaging visit 1 ]
    Compare baseline metrics from PET/MRI

  3. Baseline measure of signal enhancement ratio (SER) from MRI. [ Time Frame: Baseline imaging visit 1 ]
    Compare baseline metrics from PET/MRI

  4. Changes in SER from MRI [ Time Frame: Baseline through 6 months ]
    Compare percent change of SER from imaging visit 3 to the baseline.

  5. Changes in ADC from MRI [ Time Frame: Baseline through 6 months ]
    Compare percent change of ADC (mm2/sec) from imaging visit 3 to the baseline.

  6. Changes in SUV from PET [ Time Frame: Baseline through 6 months ]
    Compare percent change of SUV from imaging visit 3 to the baseline.


Secondary Outcome Measures :
  1. Follow-up [ Time Frame: Baseline through 5 year follow-up ]
    Compare changes in imaging metrics to disease progression (defined as clinical progression of disease through increase in lesion size or increase in number of lesions).

  2. Changes in ADC (mm2/sec) from MRI. [ Time Frame: Baseline through 2 months ]
    Compare percent change from imaging visit 2 to the baseline.

  3. Changes in SER from MRI. [ Time Frame: Baseline through 2 months ]
    Compare percent change from imaging visit 2 to the baseline.

  4. Changes in SUV from PET. [ Time Frame: Baseline through 2 months ]
    Compare percent change from imaging visit 2 to the baseline.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be ≥ 18 years old and ≤ 75 years old
  • Patients with HER2+ metastatic breast cancer
  • HER2-positive breast cancer prospectively determined on the primary tumor by a local pathology laboratory and defined as immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) (defined by ISH ratio of ≥ 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies). Only one positive result is required for eligibility
  • Estrogen/progesterone receptor positive OR negative disease allowed
  • Patients must have measurable disease in one metastatic lesion per RECIST v 1.1
  • Stage IV HER2+ breast cancer patients eligible for a new therapeutic regimen that includes HER2-targeted treatment who are naïve to that regimen
  • Estimated life expectancy of greater than six months

Exclusion Criteria:

  • Children, less than 18 years of age, will be excluded from this study
  • Metastatic breast cancer patients who are HER2 positive and have already started their current HER2-targeted therapy regimen for metastatic disease
  • Patients who have not recovered from grade 2 or higher toxicities of prior therapy to the point that they would be appropriate for re-dosing will be ineligible for study treatment
  • Patient is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 7 months after the last dose of study treatment
  • Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active infection that requires systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent).
  • Patients found to have constitutionally present non-magnetic resonance (MR) compatible ferromagnetic materials
  • Unable to lie still on the imaging table for one (1) hour
  • Inability to receive gadolinium-based contrast agent
  • Patients for whom a PET/MRI is technically not feasible (e.g. breast volume, obesity, > body mass index (BMI) 36)
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): NCT04273555


Contacts
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Contact: Anna Sorace, PhD 205-934-3116 asorace@uabmc.edu
Contact: April Riddle, BSRT 205-934-6504 ariddle@uabmc.edu

Locations
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United States, Alabama
The University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: April Riddle, BSRT    205-934-6504    ariddle@uabmc.edu   
Principal Investigator: Anna Sorace, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Anna Sorace, PhD University of Alabama at Birmingham
More Information
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Responsible Party: Anna G. Sorace, Assistant Professor, Department of Radiology and Biomedical Engineering Director, The Small Animal Facility in the Advanced Medical Imaging Research Division, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04273555    
Other Study ID Numbers: R19-149
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: February 1, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Anna G. Sorace, University of Alabama at Birmingham:
FDG-PET
MRI
quantitative imaging
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases