SUSPENDED

Hyperpolarized Carbon 13-Based Metabolic Imaging to Detect Radiation-Induced Cardiotoxicity

Conditions

Thoracic Cancer Left Sided Breast Cancer Cardiotoxicity Cardiac injury Radiation induced heart disease (RIHD)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Patients enrolled in the study will receive standard of care adjuvant or definitive breast, chest wall or thoracic radiation therapy.Cardiac mitochondrial dysfunction is a hallmark of radiation-induced cardiac injury. Reactive oxygen species (ROS) produced by ionizing radiation cause oxidation of mitochondrial proteins and alter oxidative phosphorylation and pyruvate metabolism(5). The goal of this study is to detect early changes in the mitochondrial metabolism in situ as a marker for subclinical radiation-induced cardiotoxicity.

Official Title

Single Institution Feasibility Study to Detect Radiation-Induced Cardiotoxicity in Receiving Thoracic Radiation Patients Using Hyperpolarized Carbon 13-Based Magnetic Resonance Spectroscopic Imaging

Quick Facts

Study Start:2019-12-17

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:SUSPENDED

Study ID

NCT04044872

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Benign or malignant tumor of the breast (left-sided only) or thorax 2. Stage I to IV. If stage IV, patient must have life expectancy equal to or greater than 6 months 3. ECOG performance status 0-1 4. The patient must be deemed an appropriate candidate for standard of care radiation therapy 5. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 5.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 5.2. A female of postmenopausal status is defined as patients over 60 or greater OR patients age 50-59 who meet the following criteria: * s/p bilateral oophorectomy, OR * with intact uterus without menses in the past 12 months OR, * with biochemical confirmation of post-menopausal status (estradiol in the menopausal range based on local laboratory criteria) 6. Ability to understand and the willingness to sign a written informed consent.	1. Prior radiation involving the heart 2. Subjects may not be receiving any known cardiotoxic agents for the 6 months prior to the study and during the study 3. Diagnosis of connective tissue disorders, including systemic lupus erythematosis, scleroderma, or dermatomyositis 4. Patients with stage IV cancer with life expectancy of less than 6 months 5. 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, in the opinion of the investigator, would limit compliance with study requirements 6. eGFR \<30 7. Any contraindication to MRI (including, but not limited to metal implants and devices contraindicated at 3T, breast tissue expanders, non-MR compatible IV port, claustrophobia) 8. History of psychiatric or addictive disorders that would preclude obtaining informed consent 9. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Inclusion Criteria

Exclusion Criteria

1. Benign or malignant tumor of the breast (left-sided only) or thorax
2. Stage I to IV. If stage IV, patient must have life expectancy equal to or greater than 6 months
3. ECOG performance status 0-1
4. The patient must be deemed an appropriate candidate for standard of care radiation therapy
5. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
5.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
5.2. A female of postmenopausal status is defined as patients over 60 or greater OR patients age 50-59 who meet the following criteria:
* s/p bilateral oophorectomy, OR
* with intact uterus without menses in the past 12 months OR,
* with biochemical confirmation of post-menopausal status (estradiol in the menopausal range based on local laboratory criteria)
6. Ability to understand and the willingness to sign a written informed consent.

1. Prior radiation involving the heart
2. Subjects may not be receiving any known cardiotoxic agents for the 6 months prior to the study and during the study
3. Diagnosis of connective tissue disorders, including systemic lupus erythematosis, scleroderma, or dermatomyositis
4. Patients with stage IV cancer with life expectancy of less than 6 months
5. 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, in the opinion of the investigator, would limit compliance with study requirements
6. eGFR \<30
7. Any contraindication to MRI (including, but not limited to metal implants and devices contraindicated at 3T, breast tissue expanders, non-MR compatible IV port, claustrophobia)
8. History of psychiatric or addictive disorders that would preclude obtaining informed consent
9. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Contacts and Locations

Principal Investigator

Prasanna Alluri, MD, PhD

PRINCIPAL_INVESTIGATOR

UTSW Radiation Oncology

Study Locations (Sites)

Department of Radiation Oncology; UT Southwestern Medical Center

Dallas, Texas, 75390

United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

Prasanna Alluri, MD, PhD, PRINCIPAL_INVESTIGATOR, UTSW Radiation Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-17

Study Completion Date2025-12

Study Record Updates

Study Start Date2019-12-17

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Cardiotoxicity
Cardiac injury
Radiation induced heart disease (RIHD)

Additional Relevant MeSH Terms

Thoracic Cancer
Left Sided Breast Cancer