Monitoring Radiobiological Effects in Thoracic Malignancy by Using Myocardial Perfusion Scan

NCT01913769 | Unknown DMC

• 1 other identifier: FEMH-IRB-102032-F
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Chemoradiation is an important treatment strategy of locally advanced inoperable or unresectable disease. Radiation dose is an independent predictor of a pathological response. In addition, chemotherapy has further impact on the aspect of outcome. Improvements in local treatment delivery are needed to facilitate dose escalation and to minimize toxicity. There have been sequential improvements in tumor localization, radiation planning and delivery over the years. Helical tomotherapy nowadays provides the most precise data on radiotherapy (RT) dose delivered to thoracic malignancies, and allows greater sparing of the heart from doses associated with increased complications. However, heart disease shows a wide spectrum of pathologies, and multiple risk factors related. The damage of the myocytes may lead to not only myocardial perfusion defects, but also in functional deterioration, or even in biomarkers. Since the impact of radiation-induced heart injury in patients with thoracic malignancies (including esophageal cancer, lung cancer, et al) is poorly documented, we try to delineate of RT-related cardiac effects and clinical impacts. Objective: This study aims to investigate the correlation of post-tomotherapy cardiovascular effects with myocardial perfusion and cardiac functional studies. Methods: The study plans to enroll thoracic cancer patients who will undergo local RT after complete staging. Patients will receive global risk scoring assessment (Framingham Risk Score, FRS), blood sampling for basic biochemistry, inflammatory biomarker, and myocardial perfusion image (MPI) at the time points of before and after RT. The results of MPI will be analyzed in qualitative visual interpretation of perfusion patterns, and functional quantitative data for cardiac functional parameters as well. The patients will be regular followed-up in CV OPD, following clinical judgement and guideline. The association between baseline and follow-up MPI, biomarker and clinical presentation will be further investigated. Expected results: We will obtain myocardial perfusion visual qualitative data in patients who received locoregional RT, respectively. These results will help in the understanding of pathophysiology, clinical management and follow-up of suspected RT-related heart disease.

Conditions

Thoracic Neoplasms; Late Effect of Radiation

Keywords

post-RT; myocardial perfusion images

Outcome Measures

Primary Outcomes (1)

• To investigate the correlation of post-RT cardiovascular effects with myocardial Tl-201 myocardial perfusion images

  By literature reviewing, cardiovascular functional status in patients received helical tomography has not been fully investigated yet. And the post-therapeutic heart disease tends to show a wide spectrum of pathologies and multiple risk factors. We will monitor risk factors of underlying disease, family history, metabolism, biomarkers, myocardial perfusion defect patterns, and cardiac functional parameters, in order to delineation of RT-related effects and clinical prognosis.

  July, 2014 (after 12 months of baseline study).

Study Arms (1)

Radiation therapy

Thoracic cancer patient s/p scheduled RT will be arranged to undergo Thallium-201 Myocardial Perfusion Study. The scheduled RT will be arranged by clinical judgments of radiation-oncologists. All of the patients will receive myocardial SPECT before and after the scheduled RT.

Radiation: Thallium-201 Myocardial Perfusion Study

Interventions

Thallium-201 Myocardial Perfusion Study RADIATION

One-day Tl-201 stress/rest MPI protocol with pharmacological stress, as daily practice will be applied. CZT camera with multipinhole collimator and stationary detectors scan heart simultaneously. A 10% symmetrical energy window at 140 keV was used. Electrocardiogram-gated scans will be applied. Perfusion images were reconstructed in standard axis and polar maps of the left ventricle were obtained. Scans from CZT was analyzed in consensus by two experienced readers blinded to any information on patient identification. The software package Myovation for Alcyone, QGS and QPS were used for quantitative analysis of MPI polar maps. Automated analysis to determine ejection fraction.

Radiation therapy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with thoracic malignancy who scheduled further locoregional RT.

You may qualify if:

• Patients with thoracic malignancy who scheduled further locoregional RT.
• Aged 20-80 years old.
• Classified as intermediate to high future CV risk clinically.

You may not qualify if:

• Pre-existing cardiac disease, such as prior myocardial infarction, documented CAD, congestive heart failure.
• Pregnancy.
• Any medical contraindication of stress cardiac SPECT.

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood sampling

MeSH Terms

Conditions

Thoracic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Shan-Ying Wang, M.D.

  Far Eastern Memorial Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 1, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2016
• Last Updated: August 1, 2013

Record last verified: 2013-07

Locations

TW (1)