CLINICAL TRIAL

[1-13C]pyruvate along with MRI imaging for Cardiotoxicity

Stage I
Recruiting · 18+ · All Sexes · Dallas, TX

This study is evaluating whether a new imaging technique can help detect early changes in the heart following radiation therapy.

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About the trial for Cardiotoxicity

Eligible Conditions
Unilateral Breast Neoplasms · Cardiotoxicity · Thoracic Cancers · Left Sided Breast Cancer

Treatment Groups

This trial involves 2 different treatments. [1-13C]pyruvate Along With MRI Imaging is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
[1-13C]pyruvate along with MRI imaging
DIAGNOSTICTEST
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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.
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)
Ability to understand and the willingness to sign a written informed consent.
Tissue diagnosis of benign or malignant tumor of the breast (left-sided only) or thorax
Stage I to III
ECOG performance status 0-1
The patient must be deemed an appropriate candidate for adjuvant ordefinitive radiation therapy with or without regional nodal irradiation
Radiation therapy planning should be CT scan-based using 3D conformal radiotherapy (3D-CRT), intensity modulated radiotherapy (IMRT) or volumetric arc therapy (VMAT).
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).
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: at 1 month before the radiation
Screening: ~3 weeks
Treatment: Varies
Reporting: at 1 month before the radiation
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: at 1 month before the radiation.
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether [1-13C]pyruvate along with MRI imaging will improve 1 primary outcome and 1 secondary outcome in patients with Cardiotoxicity. Measurement will happen over the course of At 1 month after the radiation.

Determination of the prognostic value decreased of myocardial mitochondrial pyruvate flux in predicting clinically significant radiation induced cardiotoxicity.
AT 1 MONTH AFTER THE RADIATION
As a secondary outcome, we will measure if decreased myocardial mitochondrial pyruvate flux results in changes in myocardial mechanical functional parameters. Towards this goal, we will measure myocardial mechanical functional parameters, including left ventricular global longitudinal strain and left ventricular myocardial deformation using cardiac MRI and correlate them with [1-13C] lactate/ [13C] bicarbonate ratio. Prior studies that cardiac MRI can detect changes in myocardial strain in patients who received whole breast radiotherapy for treatment of breast cancer.
AT 1 MONTH AFTER THE RADIATION
To determine if radiation-induced cardiac injury
AT 1 MONTH BEFORE THE RADIATION
To determine if radiation-induced cardiac injury causes myocardial mitochondrial dysfunction as measured by increase in [1-13C]lactate/ [13C]bicarbonate ratio and a decrease in [5-13C]glutamate formation in patients receiving radiotherapy to the thorax
AT 1 MONTH BEFORE THE RADIATION

Who is running the study

Principal Investigator
P. A.
Prof. Prasanna Alluri, Assistant Professor
University of Texas Southwestern Medical Center

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How serious can cardiotoxicity be?

In the first year following heart transplantation, it is possible for the recipient to experience serious cardiotoxicity. Although very common in heart transplant recipients, severe cardiotoxicity has a low incidence of death. Patients may be harmed by cardiotoxicity while still in a stable heart failure state.

Anonymous Patient Answer

What is cardiotoxicity?

A comprehensive approach in evaluating drug-induced cardiotoxicity has been described using RIFLE criteria. Clinical use of the RIFLE criteria has not yet been validated. However, these criteria are helpful to identify patients whose cardiac complications may be of clinical importance.

Anonymous Patient Answer

What causes cardiotoxicity?

Cardiotoxicity is the common adverse effect in patients using mitotane derivatives. The cardiotoxicity of these agents may be secondary, as mitotane derivatives may cause the myelosuppressants to cause cardiovascular side effects.

Anonymous Patient Answer

Can cardiotoxicity be cured?

The study shows that the curative therapy is well tolerated. The number of patients who are capable of the curative therapy with a very low incidence of cardiotoxicity is significantly higher compared with the number of patients who have cardiotoxicity. With curative therapy, the risk of new heart failure rises, but the incidence is lower than that in patients who develop cardiotoxicity. No difference was noted between the treatment group and control group. summary: Data from a recent study describes the results of a randomized study of patients with early stage of breast cancer who received or did not receive cardiotoxicity curative therapy.

Anonymous Patient Answer

What are common treatments for cardiotoxicity?

Cardiotoxicity is very commonly treated by reducing the blood lipid level, or more specifically, by antihyperlipidemic drug. It is important to administer the required dose as it may result in adverse effects in patients if not carefully managed. Also, it is very important to check coronary artery test to detect coronary artery disease in patients with hyperlipidemia. Cardiac rehabilitation could also be beneficial. Appropriate treatment to prevent cardiac dysfunction can be performed by taking the history of each patient to assess their cardiovascular status. Moreover, cardiac surgery should be considered in patients with severe cardiac injuries.

Anonymous Patient Answer

What are the signs of cardiotoxicity?

A majority of patients with a history of or signs of cardiotoxicity will have a normal EF obtained 3 or more months after surgery. One in five will have abnormal cardiac function. Serial measurements of EF after surgery are useful in determining postoperative prognosis. If patients have a history of ventricular dysfunction or cardiopulmonary bypass, caution is warranted in initiating medical or surgical management. A low EF in a preoperative setting does not necessarily predict a poor postoperative outcome.

Anonymous Patient Answer

How many people get cardiotoxicity a year in the United States?

About 1.3 million Americans will experience at least one ischemic or nonischemic event in the years ahead, most of which will occur in persons aged 45 years or older. The proportion of the population thought to be affected by CAD increases with age, but is not very prevalent.

Anonymous Patient Answer

What is the primary cause of cardiotoxicity?

The study concludes that heart failure is usually caused by myocardial ischemia that causes abnormal electrical activity in the heart that is responsible for a high left ventricular filling pressure. The result of an abnormal electrical activity in the heart is coronary artery spasm and coronary artery dilatation, which occurs after the onset of heart failure. If patients with this clinical condition do not receive proper medical treatment, they can go on to develop congestive heart failure from a severe deterioration in cardiac function. For that reason, it is crucial to treat patients with hypertension before the onset of heart failure. The main drugs that can prevent heart failure are ACE-inhibitors and angiotensin receptor drugs.

Anonymous Patient Answer

Is [1-13c]pyruvate along with mri imaging safe for people?

In this pilot study, [1-13c]pyruvate appears to be safe for people, and shows promise in the evaluation and imaging of certain cancers. Further studies are warranted to show its usefulness in evaluating cancer for metastasis and for treatment response.

Anonymous Patient Answer

How does [1-13c]pyruvate along with mri imaging work?

The use of 13C-pyruvate PET/MRI with mri imaging enables the early assessment of metabolic activity of diseased muscles. This method can be applied as an early evaluation tool for myositis of skeletal muscles.

Anonymous Patient Answer

What are the chances of developing cardiotoxicity?

Most patients without previous cardiac disease and/or with no pre-existing cardiac damage and who receive [chemotherapy including bleomycin] will develop some degree of cardiotoxicity. In contrast, patients with some prior cardiac damage as well as with patients who receive bleomycin but also with [chemotherapy including bleomycin) have a much lower chance of developing cardiotoxicity. The use of bleomycin and [chemotherapy including bleomycin could potentially increase cardiotoxicity when combined with prior cardiac damage. It is recommended that the physician assess whether a patient has prior cardiac damage using a score.

Anonymous Patient Answer

What are the common side effects of [1-13c]pyruvate along with mri imaging?

While some side effects occurred more commonly in patients with [1-13c]pyruvate compared to the control MRI, others occurred more frequently in the control MRI compared to the mri MRI. These side effects include: diarrhea, nausea, abdominal pain, nausea, vomiting, nausea, and anorexia.

Anonymous Patient Answer
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