Symptoms and General Pathology

All Conditions

Fibrosis

Antineoplastic Agents

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Pharmaceutical Solutions

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Doxorubicin

Liposomal doxorubicin

Adenosine

Neurotransmitter Agents

Cancer patients with Stage I-III breast cancer or lymphoma that have received an anthracycline agent during treatment at least 2 years prior to enrollment in this study. Adenosine stress test MRI will be performed.

Age-matched Healthy Control to cancer survivor with no history of cancer or anthracycline treatment. Adenosine stress test MRI will be performed.

Participants will receive a contrasted adenosine stress CMR examination on a 1.5T Siemens Avanto scanner (Siemens Medical Solutions, Malvern, PA) dedicated to cardiovascular imaging. Adenosine stress was selected due to attenuated endothelium dependent and -independent vasodilation after doxorubicin receipt in humans to allow the investigators to understand the potential effect of perivascular fibrosis on perfusion reserve. Standardized CMR protocols will be performed to measure LV volumes (to assess wall motion abnormalities and identify any potential myocardial dysfunction), Native T1, ECV, and myocardial perfusion reserve in the short-axis plane

Adenosine stress test MRI

Jennifer H Jordan, PhD

Kendra Rowe

Jennifer Jordan, PhD

This is a cross-sectional pilot study. The investigators seek to obtain early information pertaining to the relationship between measurements of myocardial perfusion reserve and myocardial fibrosis after receipt of Anthracycline-based chemotherapy (≥2 years prior).

The primary objective of this cross-sectional pilot study is to determine the myocardial perfusion reserve index (MPRI) in cancer survivors treated with anthracycline chemotherapy relative to similarly aged healthy comparators without a history of cancer treatment. Hypothesis: Cancer survivors treated with anthracycline chemotherapy will have a lower MPRI than similarly aged healthy comparators without a history of cancer treatment.The secondary objective of this cross-sectional pilot study is to determine if MPRI is associated with myocardial fibrosis measured non-invasively with cardiovascular magnetic resonance imaging. Hypothesis: MPRI will be inversely associated with fibrosis burden

Study participants will be consented with pre-study data collection recorded. No randomization will occur as this is a cross-sectional study. Participants in both the cancer survivor and control groups will complete one study visit. No follow-up will be completed.

Myocardial Perfusion and Fibrosis in Cancer Survivors

The myocardial perfusion reserve index (MPRI) will be measured noninvasively with adenosine stress CMR imaging after dual-bolus first-pass perfusion with gadolinium contrast. The slope of the myocardial signal intensity curve is computed and normalized by the slope of the blood pool signal intensity curve for both rest and stress. MPRI is calculated as the ratio of the stress slope divided by the rest slope.

Measured noninvasively with CMR imaging. For myocardial fibrosis quantification with T1 endocardial and epicardial contours are drawn to delineate the myocardium; mean T1 (pre- and post-contrast) is calculated from the pixels within the myocardium. Expected range of T1 is 900-1250ms with higher T1 values considered a worsened outcome.

Measured noninvasively with CMR imaging. The ECV is calculated from the mean myocardial T1 and LV blood T1 pre- and post-contrast. Expected range of ECV is 20-40% with higher ECV values representing a worse outcome.

Wake Forest University

Virginia Commonwealth University

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants will be randomized 1:1 to XRT group and stratified by receipt of chemotherapy and cardiac risk factors and will complete:

* Cardiac MRI and blood tests within 1 month prior to start of radiation therapy.
* Radiation therapy 1x daily for 5 days over 1 week.
* End of radiation therapy visit with blood tests.
* 6 month follow up visit with cardiac MRI, blood tests, questionnaires, and photographic imaging.
* 12 month follow up visit with questionnaires and photographic imaging.

Accelerated Proton Beam Radiation Therapy (PBT)

Accelerated Photon Radiation Therapy (XRT)

Rachel Jimenez, MD

This research is being done to see if proton beam radiation therapy (PBT) results in fewer changes to a participant's heart measured with MRI-imaging than conventional or "photon" radiation therapy (XRT) for participants with non-metastatic left sided breast cancer.

The names of the two study groups in this research study are:

* Proton Radiation Therapy (PBT)
* Conventional or "Photon" Radiation Therapy (XRT)

This is a randomized phase II trial comparing participants with stage II-III breast cancer treated with accelerated Proton Beam Radiation Therapy (PBT) versus accelerated conventional photon radiation therapy (XRT) inclusive of the regional lymph nodes.

Participants will be randomized into one of two study groups: proton beam radiation therapy versus photon radiation therapy. Randomization means that participants are put into a group by chance.

Study procedures includes screening for eligibility, study treatment visits, Cardiac Magnetic Resonance Imaging (MRI), blood tests, and questionnaires.

The National Cancer Institute, American Society of Clinical Oncology, and Claflin Grant are supporting this research by providing funding for the research study.

All women of all races and ethnic groups are eligible for this trial.

Ultrahypofractionation and Normal Tissue Toxicity

Proton Versus Photon Ultrahypofractionated Radiation Therapy and Its Impact on Normal Tissue

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

The primary outcome is to determine whether participants who receive accelerated PBT show no increase in myocardial fibrosis on Cardiac MRI (CMR) compared to an estimated 4% increase in extracellular matrix volume fraction (ECV) in participants who receive accelerated XRT. CMR will be performed using a 3T system (Skyra, Siemens). The T1 phase on MRI will be used to measure ECV.

GLS will be measured using feature tracking from the Steady-state free precession (SSFP) MRI cine images (Medis Suite, Leiden).

Cardiac Biomarkers will be measured using enzyme-linked immunoassay (ELISA).

Assessed by photographic imaging of the breast, chest wall and reconstructed breast, the Breast Q: Mastectomy Module (Postoperative) 2.0, the Breast Q: Reconstruction Module (Postoperative) 2.0, and the Breast-Q: Breast Conserving Therapy Module (Postoperative) 2.0 questionnaires which are rigorous patient-report outcome measures. Modules grade Quality of Life (QOL) and Satisfaction Domains related to post-operative care and experiences. All BREAST-Q scales are transformed into scores that range from 0-100. T. A higher score means greater satisfaction or better QOL (depending on the scale).

Assessed by the Thoracic Focused Assessment with Sonography for Trauma, Triage, and Tracking (TFAST), the Penn Shoulder Scale (PSS), and the Disabilities of the Arm, Shoulder and Hand (DASH) Shoulder Function Scale. TFAST is an objective and highly reproducible functional assessment tool of the arm and shoulder. The PSS is a patient-reported outcome tool which provides a shoulder-specific metric and distinguishes between finer levels of functioning. Scores range from 0 to 100 with a score of 100 indicating low pain, high satisfaction, and high function. DASH is a 30-item, validated, patient-reported scale that captures upper extremity functionality and mobility and maintains high construct validity and responsiveness in the breast cancer population. Questions are graded on a Likert scale with scores ranging from "1" Strongly Disagree to "5" Strongly Agree, where a cumulative score of 0 is graded no disability and 100 is most severe disability.

National Cancer Institute (NCI)

American Society of Clinical Oncology

Massachusetts General Hospital

Principal Investigator

Heart and Blood Diseases

Wounds and Injuries

Heart Failure

Radiation Fibrosis Syndrome

Syndrome

Heart Diseases

Radiation Injuries

Antihypertensive Agents

Vasoconstrictor Agents

Losartan

Angiotensin II

Giapreza

Angiotensinogen

Angiotensin II Type 1 Receptor Blockers

Angiotensin Receptor Antagonists

Participants will receive radiation therapy 5x weekly over 1-6 weeks. Participants will receive Losartan 1x daily during radiation therapy and for up to 6 months afterward then be followed for 1 year

Radiation Therapy

This study is being done to see if losartan affects the chances of developing radiation-induced heart failure in patients who are receiving radiation therapy as part of standard of care treatment for breast cancer.

The interventions involved in this study are:

* Losartan
* Radiation Therapy (standard of care)

This is a pilot study examining whether losartan prevents radiation therapy-induced myocardial fibrosis (thickening of the heart tissue), which can cause heart failure, in breast cancer patients receiving radiation therapy.

Losartan is an U.S. Food and Drug Administration (FDA) approved drug used to treat hypertension (high blood pressure) and heart failure. The U.S. Food and Drug Administration (FDA) has not approved losartan for use in the treatment of breast cancer.

The FDA has approved radiation therapy as a treatment option for breast cancer.

The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. It is expected participants will be on the study for 1 year.

It is expected that about 10 people will take part in this research study.

Losartan in Prevention of Radiation-Induced Heart Failure

The Role of Losartan in the Prevention of Early Structural Changes Associated With Radiation-Induced Heart Failure

The primary endpoint is detectable decrease in extracellular volume as measured by cardiac MRI

The secondary objective of this study is to compare pre- and post-Radiation Therapy changes in serum TGF-β levels

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Myocardial Perfusion and Fibrosis in Cancer Survivors	NCT03191461	Myocardial Fibr... Myocardial Inju... Chemotherapeuti...	Adenosine stres...	21 Years - 85 Years	Virginia Commonwealth University
Ultrahypofractionation and Normal Tissue Toxicity	NCT05912231	Breast Cancer Breast Cancer F... Breast Cancer S... Breast Cancer S... Myocardial Fibr...	Accelerated Pro... Accelerated Pho...	18 Years -	Massachusetts General Hospital
Myocardial Perfusion and Fibrosis in Cancer Survivors	NCT03191461	Myocardial Fibr... Myocardial Inju... Chemotherapeuti...	Adenosine stres...	21 Years - 85 Years	Virginia Commonwealth University
Losartan in Prevention of Radiation-Induced Heart Failure	NCT05607017	Breast Cancer Myocardial Fibr... Radiation-Induc...	Losartan Radiation Thera...	18 Years -	Massachusetts General Hospital

Spots Global Cancer Trial Database for myocardial fibrosis