Breast Cancer, FemaleNCT01758419
The Role of Myocardial SPECT in Evaluation of Irradiation-induced Changes.
An observational study of Breast Cancer, Female, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Helical tomotherapy nowadays provides the most precise data on radiotherapy (RT) dose delivered to each region of the heart in left-sided breast cancer therapy, which allows greater sparing of the heart from doses associated with increased complications. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Female
- What is being tested?
- Thallium-201 Myocardial Perfusion Study
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2012to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients with breast cancer who scheduled further regional RT. Groups of left-sided breast cancer (tomotherapy, conventional RT), and right breast cancer (conventional RT).
Who may be able to join
- Female patients with breast cancer who scheduled further regional RT. Groups of left-sided breast cancer (tomotherapy, conventional RT), and right breast cancer (conventional RT).
- Aged 20-80 years old.
Who cannot join
- Pre-existing cardiac disease, such as prior myocardial infarction, documented CAD, congestive heart failure.
- Pregnancy
- Any medical contraindication of cardiac SPECT.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorial Hospital
New Taipei City, 220
+886-277282152, irb@mail.femh.otg.tw
About this study
Official title: The Role of Myocardial SPECT in Evaluation of Irradiation-induced Changes With Myocardial Perfusion, Cardiac Function, Metabolism and Clinical Prognosis.
Helical tomotherapy nowadays provides the most precise data on radiotherapy (RT) dose delivered to each region of the heart in left-sided breast cancer therapy, which 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. In this study, we will monitor cardiovascular (CV) risk factors, metabolism, biomarkers, myocardial perfusion defect patterns, and cardiac functional parameters, in order to delineate of RT-related effects and clinical impacts.
Objective: The pilot study aims to investigate the correlation of post-tomotherapy cardiovascular effects with myocardial perfusion and cardiac functional studies.
Methods: The study plans to enroll female breast cancer patients who will undergo local RT after their surgery. 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. The association between baseline and follow-up MPI, biomarker and clinical presentation will be further investigated.
Read the detailed description
- Inclusion Criteria:
- Female patients with breast cancer who scheduled further regional RT. Groups of left-sided breast cancer (tomotherapy, conventional RT), and right breast cancer (conventional RT).
- Aged 20-80 years old.
- Exclusion Criteria
- Pre-existing cardiac disease, such as prior myocardial infarction, documented CAD, congestive heart failure.
- Pregnancy
- Any medical contraindication of cardiac SPECT.
- Estimated Case Number 20 female patients of each groups, respectively Group 1: Left-sided breast cancer, planning to received helical tomography Group 2: Left-sided breast cancer, planning to received local conventional RT Group 3: Right-sided breast cancer, planning to received local RT
- Patients with breast cancer s/p operation will be transferred to CV OPD for initial cardiovascular risk factors assessment.
- Past history, family history, basic lab data and Framingham cardiovascular risk assessment will be applied. Intermediated to high risk need further work-up, and undergo SPECT before further RT course.
- All enrolled subjects provide basic demographic data and sign informed consents.
- Myocardial perfusion images for baseline evaluation before RT.
- The patients received scheduled treatment plan, including RT.
- Follow-up CV OPD every 3 months.
- Post-therapeutic myocardial perfusion study 12 months after first CV OPD visit.
- Comparing the clinical follow-up data between groups, including global functional assessments, blood sampling data, myocardial perfusion scan, and quantitative cardiac functional parameters.
Blood sampling
Myocardial perfusion study- Patients referred for SPECT MPI for evaluation of CAD underwent a 1-day Tl-201 stress/rest MPI protocol, as daily practice in FEMH. Pharmacological stress was induced by standard dipyridomale infusion. Tl-201 of 2 mCi was injected after 7 min of induced stress. Each scan will be performed on an ultrafast CZT camera (Discovery 530 NMc, GE Healthcare). CZT images were reconstructed on the workstation using a dedicated iterative algorithm with maximum likelihood expectation maximization. Perfusion images in standard axis (short axis, vertical long axis, horizontal long 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 with a 17-segment model for the left ventricle. Automated analysis of gated acquisitions from high-dose (rest) scans was performed to determine left ventricular ejection fraction. Integrated clinical information, follow-up and nuclear medicine cardiac scans performed in the time points of before \& after RT will be collected and analyzed.
- Conditions
- Breast Cancer, Female
- Being tested
- Thallium-201 Myocardial Perfusion Study
- Keywords
- post-RT, myocardial perfusion images
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thallium-201 Myocardial Perfusion StudyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Tomotherapy | Breast cancer female 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. Comparing the clinical follow-up data between different groups (left-sided s/p tomography, left-sided s/p conventional RT, and right-sided RT), respectively. Receives: Radiation: Thallium-201 Myocardial Perfusion Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Dec, 2013 (after 12 months of baseline study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2014 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shan-Ying Wang, M.D., Principal investigator, Far Eastern Memorial Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758419
- Sponsor's protocol ID
- FEMH-IRB-101085-F
- Status last verified
- Jul 2013
- First submitted
- 27 Dec 2012
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang SY, Lin KH, Wu YW, Yu CW, Yang SY, Shueng PW, Hsu CX, Wu TH. Evaluation of the cardiac subvolume dose and myocardial perfusion in left breast cancer patients with postoperative radiotherapy: a prospective study. Sci Rep. 2023 Jun 29;13(1):10578. doi: 10.1038/s41598-023-37546-7.
PubMed 37386034
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Myocardial SPECT in Evaluation of Irradiation-induced Changes With Myocardial Perfusion, Cardiac Function, Metabolism and Clinical Prognosis.
- ClinicalTrials.gov ID
- NCT01758419
- Acronym / sponsor ID
- FEMH-IRB-101085-F
- Conditions
- Breast Cancer, Female
- Keywords
- post-RT, myocardial perfusion images
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 1 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Helical tomotherapy nowadays provides the most precise data on radiotherapy (RT) dose delivered to each region of the heart in left-sided breast cancer therapy, which 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. In this study, we will monitor cardiovascular (CV) risk factors, metabolism, biomarkers, myocardial perfusion defect patterns, and cardiac functional parameters, in order to delineate of RT-related effects and clinical impacts.
Objective: The pilot study aims to investigate the correlation of post-tomotherapy cardiovascular effects with myocardial perfusion and cardiac functional studies.
Methods: The study plans to enroll female breast cancer patients who will undergo local RT after their surgery. 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. The association between baseline and follow-up MPI, biomarker and clinical presentation will be further investigated.
Detailed description
- Inclusion Criteria:
- Female patients with breast cancer who scheduled further regional RT. Groups of left-sided breast cancer (tomotherapy, conventional RT), and right breast cancer (conventional RT).
- Aged 20-80 years old.
- Exclusion Criteria
- Pre-existing cardiac disease, such as prior myocardial infarction, documented CAD, congestive heart failure.
- Pregnancy
- Any medical contraindication of cardiac SPECT.
- Estimated Case Number 20 female patients of each groups, respectively Group 1: Left-sided breast cancer, planning to received helical tomography Group 2: Left-sided breast cancer, planning to received local conventional RT Group 3: Right-sided breast cancer, planning to received local RT
- Patients with breast cancer s/p operation will be transferred to CV OPD for initial cardiovascular risk factors assessment.
- Past history, family history, basic lab data and Framingham cardiovascular risk assessment will be applied. Intermediated to high risk need further work-up, and undergo SPECT before further RT course.
- All enrolled subjects provide basic demographic data and sign informed consents.
- Myocardial perfusion images for baseline evaluation before RT.
- The patients received scheduled treatment plan, including RT.
- Follow-up CV OPD every 3 months.
- Post-therapeutic myocardial perfusion study 12 months after first CV OPD visit.
- Comparing the clinical follow-up data between groups, including global functional assessments, blood sampling data, myocardial perfusion scan, and quantitative cardiac functional parameters.
Blood sampling
Myocardial perfusion study- Patients referred for SPECT MPI for evaluation of CAD underwent a 1-day Tl-201 stress/rest MPI protocol, as daily practice in FEMH. Pharmacological stress was induced by standard dipyridomale infusion. Tl-201 of 2 mCi was injected after 7 min of induced stress. Each scan will be performed on an ultrafast CZT camera (Discovery 530 NMc, GE Healthcare). CZT images were reconstructed on the workstation using a dedicated iterative algorithm with maximum likelihood expectation maximization. Perfusion images in standard axis (short axis, vertical long axis, horizontal long 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 with a 17-segment model for the left ventricle. Automated analysis of gated acquisitions from high-dose (rest) scans was performed to determine left ventricular ejection fraction. Integrated clinical information, follow-up and nuclear medicine cardiac scans performed in the time points of before \& after RT will be collected and analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tomotherapy | – | Radiation: Thallium-201 Myocardial Perfusion StudyBreast cancer female 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. Comparing the clinical follow-up data between different groups (left-sided s/p tomography, left-sided s/p conventional RT, and right-sided RT), respectively. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients with breast cancer who scheduled further regional RT. Groups of left-sided breast cancer (tomotherapy, conventional RT), and right breast cancer (conventional RT).
Key inclusion criteria (2 listed)
- Female patients with breast cancer who scheduled further regional RT. Groups of left-sided breast cancer (tomotherapy, conventional RT), and right breast cancer (conventional RT).
- Aged 20-80 years old.
Key exclusion criteria (3 listed)
- Pre-existing cardiac disease, such as prior myocardial infarction, documented CAD, congestive heart failure.
- Pregnancy
- Any medical contraindication of cardiac SPECT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thallium-201 Myocardial Perfusion StudyOne-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 | Tomotherapy |
Primary outcome
To investigate the correlation of post-RT cardiovascular effects with myocardial Tl-201 myocardial perfusion images
Time frame: Dec, 2013 (after 12 months of baseline study).
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
- Derived from this study: PubMed 37386034Wang SY, Lin KH, Wu YW, Yu CW, Yang SY, Shueng PW, Hsu CX, Wu TH. Evaluation of the cardiac subvolume dose and myocardial perfusion in left breast cancer patients with postoperative radiotherapy: a prospective study. Sci Rep. 2023 Jun 29;13(1):10578. doi: 10.1038/s41598-023-37546-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shan-Ying Wang, M.D. principal investigator
Far Eastern Memorial Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, Female, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shan-Ying Wang, M.D. (+886-277282462, sywang@mail.femh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the correlation of post-RT cardiovascular effects with myocardial Tl-201 myocardial perfusion images (time frame: Dec, 2013 (after 12 months of baseline study).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01758419, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2014.