Cardiotoxicity of Radiation Therapy (CTRT)

NCT02769299 | Completed DMC

• 1 other identifier: UPCC 04115
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this proposal is to determine the utility of sensitive imaging and biomarker measures in detecting subclinical cardiotoxicity across a spectrum of radiation doses to the heart. We will focus specifically on patients receiving photon or proton chest radiotherapy. Our broad working hypothesis is that RT induces early, subclinical CV injury, as evidenced by cardiomyocyte inflammation and necrosis, and worsening CV function.

Conditions

Breast Cancer; Lung Cancer; Mediastinal Lymphomas

Outcome Measures

Primary Outcomes (1)

• Number of CV injury

  8 months

Interventions

Radiation Therapy RADIATION

less than 1 Gy with protons to 4-8 Gy with photons

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

breast cancer, lung cancer, and mediastinal lymphomas

You may qualify if:

• Age 18 years or older.
• Patients with left sided breast cancer newly initiating fractionated whole breast/chest wall with regional nodal photon or proton radiation therapy.
• Patients with right sided breast cancer with newly initiating fractionated photon or proton radiation therapy with mediastinal nodal proton or photon radiation therapy that will include cardiac dose.
• Lung cancer patients treated with definitive intent (greater than or equal to 50 Gy) using fractionated thoracic radiotherapy with proton or photon radiation therapy. Patients receiving concurrent chemotherapy will be allowed.
• Patients with mediastinal lymphoma, whose lowest extent of mediastinal disease is at or below the level of the carina, treated with consolidative radiation with definitive intent (greater than or equal to 20 Gy) using fractionated thoracic radiotherapy with proton or photon radiation therapy.
• Ability to read and comprehend English.

You may not qualify if:

• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• Patients receiving stereotactic body radiotherapy
• Patients unable to undergo MR imaging will be excluded from the optional MR, but will not be excluded from the main study.
• Life expectancy less than 12 months
• Vulnerable patients as noted in 5 below (children, pregnant women, fetuses, neonates, or prisoners)
• Patients with estimated glomerular filtration rate of less than 60 ml/min/1.73sq.m will be excluded from the optional MR, but will not be excluded from the main study.
• Non-diagnostic echocardiography windows

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Bonnie Ky, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 11, 2016
• Study Start: June 2, 2015
• Primary Completion: November 26, 2018
• Study Completion: November 26, 2018
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

US (1)