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Group photo of the members of the Advanced Cardiovascular Imaging LaboratoryGroup photo of the members of the Advanced Cardiovascular Imaging Laboratory
Members of the Advanced Cardiovascular Imaging Laboratory

Effect of Cardiotoxic Anticancer Chemotherapy on the Metabolism of [1-13C]Pyruvate in Cardiac Mitochondria (HP Cardiotox)

Inclusion criteria

  • Breast cancer tissue diagnosis
  • Doxorubicin neoadjuvant treatment plan
  • Neoadjuvant patients
  • Above the age of 18, F/M
  • Read and speak English / Spanish
  • Willing to use contraception

Exclusion criteria

  • Alternative chemotherapy or
  • Left sided radiotherapy
  • Any other investigational agent
  • Uncontrolled illness
  • Macro metastatic disease
  • Pregnant
  • Diabetic
  • Sickle cell disease
  • Hemolytic anemia

 


Contraindication to MRI: claustrophobia, metal in body, facial tattoos / major tattoos, tissue expanders

Goal

To detect early changes in the mitochondrial metabolism, in situ, as a marker for asymptomatic, subclinical, doxorubicin induced cardiotoxicity.

Brief Summary

The anthracycline, doxorubicin, was first introduced to the world of medicine in the 1960's. Today, it continues to be an effective antineoplastic drug that is widely used as a drug of choice for chemotherapy. It is, however, known to present a risk of cardiotoxicity - even at relatively low cumulative doses. Even though the incidence of subclinical cardiotoxicity is not known, it is clear that doxorubicin carries a potential risk for causing late effects in cancer survivors. This drug introduces systemic toxicity that may contribute to cardiac metabolic stress - the main cardiotoxic mechanism, however, involves the cardiac mitochondria.

Protocol snapshot

  • On the day of the metabolic cardiac MR scan an IV line will be inserted
  • A bolus of oral glucose will be administered to prepare the heart for the metabolic study
  • A metabolic cardiac MR study will follow for 60 min, including IV tracer administration and carbon13 detection
  • Total duration: 4 hours
  • Separate conventional cardiac MRI sessions may be completed in certain participants
  • Close monitoring for the participant well-being before, during and after the scan with EKG, blood pressure, heart rate, and temperature
  • Less than 5 oz of blood will be drawn though the IV, at preset intervals throughout the study duration

Diagnosis: Breast cancer

Ages Eligible for study: 18 +

Sexes eligible for study: All

Accepts healthy volunteers: No

Areas of recruitment: UTSW, Parkland Hospital

Time frame: 4 years

Visit duration: 4 hours

Total MRI scan time: 60 minutes

Using a U.S. FDA-regulated metabolic substrate: Yes - Hyperpolarized 13C-pyruvate

Study phase: Early Phase 1

Study arms

Formal Study

  • Metabolic study visit 1: baseline prior to beginning standard-of-care, neoadjuvant, doxorubicin
  • Metabolic study visit 2: after doxorubicin completion
graphic representation of the Formal Study arm
Formal Metabolic Study

Feasibility Study

  • Metabolic study visit 1: after doxorubicin completion
  • Metabolic study visit 2: at 1 to 6 months after the first scan following medical therapy
Feasibility Study Graphic
Metabolic Feasibility Study

A separate conventional cardiac MRI scan is offered as an option for the study participants. This can be done on the same day as the study visit, or on another day. It will take approximately 1 ½ hours to complete, where the participant will be injected with a standard contrast agent – Gadolinium.

The Standard of Care treatment will not be affected in any way with this study; the participants will not be charged for any research related activity; they will receive $100/scan, lunch/scan, and valet parking validation/scan.