Effect of Cardiotoxic Anticancer Chemotherapy on the Metabolism of [1-13C]Pyruvate in Cardiac Mitochondria
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/17/2018 |
| Start Date: | July 1, 2018 |
| End Date: | March 2022 |
| Contact: | Aneela Afzal |
| Email: | aneela.afzal@utsouthwestern.edu |
| Phone: | 214-645-6269 |
The anthracycline doxorubicin, first introduced in the 1960's, continues to be an effectively
utilized antineoplastic drug. Even at relatively low cumulative doses there is risk of
cardiotoxicity. However, the incidence of subclinical cardiotoxicity is not known, carrying a
potential risk for late effects in cancer survivors. Doxorubicin has systemic toxicity that
may contribute to cardiac metabolic stress, but the main cardiotoxic mechanism involves
cardiac mitochondria. The goal of this study is to detect early changes in the mitochondrial
metabolism in situ as a marker for subclinical doxorubicin induced cardiotoxicity.
utilized antineoplastic drug. Even at relatively low cumulative doses there is risk of
cardiotoxicity. However, the incidence of subclinical cardiotoxicity is not known, carrying a
potential risk for late effects in cancer survivors. Doxorubicin has systemic toxicity that
may contribute to cardiac metabolic stress, but the main cardiotoxic mechanism involves
cardiac mitochondria. The goal of this study is to detect early changes in the mitochondrial
metabolism in situ as a marker for subclinical doxorubicin induced cardiotoxicity.
This is a prospective, single-center study in women and men with breast cancer requiring
doxorubicin treatment. The study will be conducted in parallel to the standard clinical care,
at dedicated visits.
In this study patients will undergo a cardiac magnetic resonance (MR) signal detection after
injection of hyperpolarized carbon-13 pyruvate. The study will be performed before the course
of doxorubicin, and after completing doxorubicin treatment.
Patients will be screened prior to enrollment based on study specific inclusion and exclusion
criteria and MRI safety criteria.
On the day of the metabolic cardiac MR scan an IV line will be inserted and the participant
will receive a bolus of oral glucose. The ingestion of glucose will be required to prepare
the state of the heart for metabolic imaging. Following this preparation the participant will
undergo a cardiac MR study of about 45 minutes, including carbon-13 dedicated sequences.
A separate dedicated cardiac MRI session may be completed in certain participants.
In part I 10 patients will be studied after completion of doxorubicin therapy for correlation
with cardiac mechanical function.
In part II up to 100 patients will be studied before and after completion of doxorubicin
therapy for identification of subclinical cardiac metabolic changes.
doxorubicin treatment. The study will be conducted in parallel to the standard clinical care,
at dedicated visits.
In this study patients will undergo a cardiac magnetic resonance (MR) signal detection after
injection of hyperpolarized carbon-13 pyruvate. The study will be performed before the course
of doxorubicin, and after completing doxorubicin treatment.
Patients will be screened prior to enrollment based on study specific inclusion and exclusion
criteria and MRI safety criteria.
On the day of the metabolic cardiac MR scan an IV line will be inserted and the participant
will receive a bolus of oral glucose. The ingestion of glucose will be required to prepare
the state of the heart for metabolic imaging. Following this preparation the participant will
undergo a cardiac MR study of about 45 minutes, including carbon-13 dedicated sequences.
A separate dedicated cardiac MRI session may be completed in certain participants.
In part I 10 patients will be studied after completion of doxorubicin therapy for correlation
with cardiac mechanical function.
In part II up to 100 patients will be studied before and after completion of doxorubicin
therapy for identification of subclinical cardiac metabolic changes.
Inclusion Criteria:
- Breast cancer tissue diagnosis
- Plan for treatment with doxorubicin
- Neoadjuvant patients
- Age ≥ 18 years
- Ability to understand and the willingness to sign a written informed consent
- While all races and ethnicities will be included, subjects must be able to read and
speak the English language. Once the protocol is established, Spanish-speaking
participants will be included.
- Women of child-bearing potential must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to study entry, for the duration of
study participation. Should a woman become pregnant or suspect she is pregnant while
participating in this study, she should inform her treating physician immediately.
Exclusion Criteria:
- Subjects who have alternative chemotherapy or left sided radiotherapy
- Subjects who are receiving any other investigational agents
- Subjects with known macro metastases should be excluded from this clinical trial
because of their poor prognosis.
- 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 would limit compliance with
study requirements.
- Pregnant
- Diabetic Contraindication to MRI - claustrophobia, metal in body, facial tattoos /
major tattoos, tissue expanders
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