To Correlate RPM Respiratory-gating Methods Analyses, Treatment Response, and Normal Tissue Metabolic Effect.NCT02063633
PET With Respiratory Gating Technique in Evaluation of Response and Normal Tissue Effect in Thoracic Cancer
An observational study of To Correlate RPM Respiratory-gating Methods Analyses, Treatment Response, and Normal Tissue Metabolic Effect. and Application in Clinical Outcomes and Prediction of Prognosis., run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Technologic advances in the field of radiation oncology have made in possible to deliver a highly conformal and accurate radiation dose to a target tissue. Accompanying the rapid implementation of these novel techniques is often a reduction in the radiation margins, which reinforces the importance of accurate target… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- To Correlate RPM Respiratory-gating Methods Analyses, Treatment Response, and Normal Tissue Metabolic Effect., Application in Clinical Outcomes and Prediction of Prognosis.
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2014to Dec 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Thoracic cancer who will be scheduled further radiotherapy
Who may be able to join
- Patients with thoracic cancer who will be scheduled further radiotherapy.
- Aged 20-80 years old.
Who cannot join
- Pre-existing chronic lung disease, such as COPD, interstitial lung disease, cystic lung disease, et al.
- Pregnancy.
- Any medical contraindication of FDG PET study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Far Eastern Memorial Hospital
New Taipei City, 220
Shu-Wen Chang, Professor, +886-277282152, irb@mail.femh.otg.tw
Shan-Ying Wang, M.D.
About this study
Official title: Radiotherapeutic Tumor Response and Normal Tissue Effect in Treating Thoracic Malignancy : as Comparing With Free-breathing Non-gating Methods.
Technologic advances in the field of radiation oncology have made in possible to deliver a highly conformal and accurate radiation dose to a target tissue. Accompanying the rapid implementation of these novel techniques is often a reduction in the radiation margins, which reinforces the importance of accurate target delineation, and reduces the side effect of therapy.
F-18 FDG PET/CT is widely used in oncology, including complete whole body staging, restaging and monitoring of tumor response in different types of cancers. As to non-oncology application, inflammation in almost any tissue will result in increased FDG accumulation. However, the normal tissue with sparing radiation may show subtle change, and would be difficult to be detected. FDG PET/CT was limited in the spatial resolution of 5 mm and low FDG-avid disease. To be evaluation of the interval change of metabolic response before and after radiotherapy of thoracic malignancies, we plan to initiate a prospective study trail the takes advantages of recent technical advances of technique in 4-dimensional PET/CT (4-D PET/CT) with respiratory gating system.
Read more
Respiratory motion creates artifacts in PET and PET/CT images, and can alter diagnosis. The tumor edge would be blurred due to respiratory movement, and be underestimated the uptake value. Also, semi-quantitative measurement, standard uptake value (SUV), combined with parameters such as the lesion site and shape, which is commonly used to make the final assessment of disease would be mis-estimated.
The study aims to investigate the correlation of 4-D PET/CT with respiratory gating methods and free breathing PET/CT when processing primary thoracic malignancy and normal tissue effect.
Read the detailed description
Radiation pneumonitis is the dose-limiting toxicity in thoracic radiotherapy (RT) for thoracic malignancy. It occurs beginning after the initiation of RT for up to 6 months characterized by cough, shortness of breath, and changes in lung function. A mortality rate approaches 50% in severe radiation pneumonitis [4]. Dosimetric parameters, such as the percentage of lung volume irradiated ≧20 Gy (V20) and the mean lung dose (MLD), provide a guide to assess the risk of radiation pneumonitis in the treatment planning process. However, the parameters have poor predictive power for individual risk. The appearance of radiation lung injury shown in computed tomography (CT) was characterized by and early and a late phase. Since, radiation pneumonitis is characterized by the migration of leukocytes from the blood to irradiated lung tissue; thus, on FDG-PET imaging, more intense inflammatory responses will result in greater FDG uptake. Identifying an early sign or precursor of normal tissue damage helps predicting the delayed organ dysfunction.
In combined PET/CT, CT is used for localization and correction for attenuation in the PET images. An accurate spatial registration of PET and CT image sets is a prerequisite for accurate diagnosis and SUV measurement. However, because of respiration, and the difference in the acquisition time required to image the thorax between PET (6-9 minutes) and CT (~15 seconds), spatial misalignment between the 2 image sets is not uncommon. This misalignment significantly compromises the interpretation of PET images, resulting in mislocalization of the lesion and inaccurate quantitation of the SUV. The main cause of these artifacts is the dynamic interaction between transaxial image acquisition and the asynchronous motion of tumor and normal tissues. To account for motion effects, respiratory gating techniques have been developed.
A more sophisticated respiratory-motion monitoring system is the Real-Time Position Management respiratory gating system (RPM). The system includes a video camera that measures respiratory motion by tracking the vertical displacement of 2 infrared reflective markers rigidly mounted on a plastic block placed on the patient's thorax. The motion of the block is displayed by a graphical interface on the RPM workstation. It has been used in gated radiotherapy of lung, respiratory-gated CT, and 4-D CT, as well as respiratory-gated PET imaging.
We plan to enroll patients with thoracic cancer who scheduled further radiotherapy. Patients with pre-existing chronic lung disease, such as COPD, interstitial lung disease, cystic lung disease, et al, will be excluded. The FDG PET/CT will be performed before the radiotherapy (baseline study), and 30-45 days after completing radiotherapy (2nd study). Free-breathing whole body scan will be performed after 40 minutes, and regional 4D PET/CT with RPM method for chest was performed subsequently. These patients will be follow-up in radiation oncology clinics, any radiation-related adverse effect and long-term prognosis will be recorded. The association between the data analysis will be further investigated.
We will obtain better delineation of the correlation and the differences between free-breathing PET/CT 4-D PET/CT with RPM respiratory-gating methods in processing tumor metabolism, more over, to assess normal tissue metabolic effect. And the further work is trying to find if the application helps in clinical outcomes and prediction of prognosis of the technique of 4-D PET/CT with RPM respiratory-gating methods.
- Conditions
- To Correlate RPM Respiratory-gating Methods Analyses, Treatment Response, and Normal Tissue Metabolic Effect., Application in Clinical Outcomes and Prediction of Prognosis.
- Keywords
- Thoracic malignancy, irradiation, respiratory gating system PET
What is being measured
The primary outcome is the main question the study is designed to answer.
normal tissue effect
The patient should be fasting prior to the exam for at least 6 hours. Before the radiopharmaceutical injection, we will take a sample of blood from a vein to test the blood sugar level. High levels of circulating glucose essentially compete with radioactive FDG in the exam, and image degradation may occur. Then F-18 FDG PET/CT study with 10 mCi tracer was injected from vein. All PET/CT studies were performed on the hybrid PET/CT scanner (Discovery VCT, General Electric Medical Systems).After uptake time of 60 minutes, whole body FDG PET from the vertex of the skull to the proximal thighs in 3D mode at 60 minutes after intravenous administration of FDG. After 60 minutes of the first imaging, delayed 4-D PET/CT with RPM respiratory gating method will be applied to lung fields. The time-points of FDG PET/CT are before radiotherapy (baseline study), and 30-45 days after completing radiotherapy (2nd study).
Measured: Dec, 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Correlate RPM Respiratory-gating Methods Analyses, Treatment Response, and Normal Tissue Metabolic Effect.Studies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063633
- Sponsor's protocol ID
- 102118-F
- Status last verified
- Feb 2014
- First submitted
- 7 Feb 2014
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapeutic Tumor Response and Normal Tissue Effect in Treating Thoracic Malignancy : as Comparing With Free-breathing Non-gating Methods.
- ClinicalTrials.gov ID
- NCT02063633
- Acronym / sponsor ID
- 102118-F
- Conditions
- To Correlate RPM Respiratory-gating Methods Analyses, Treatment Response, and Normal Tissue Metabolic Effect., Application in Clinical Outcomes and Prediction of Prognosis.
- Keywords
- Thoracic malignancy, irradiation, respiratory gating system PET
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 14 Feb 2014 (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.
Technologic advances in the field of radiation oncology have made in possible to deliver a highly conformal and accurate radiation dose to a target tissue. Accompanying the rapid implementation of these novel techniques is often a reduction in the radiation margins, which reinforces the importance of accurate target delineation, and reduces the side effect of therapy.
F-18 FDG PET/CT is widely used in oncology, including complete whole body staging, restaging and monitoring of tumor response in different types of cancers. As to non-oncology application, inflammation in almost any tissue will result in increased FDG accumulation. However, the normal tissue with sparing radiation may show subtle change, and would be difficult to be detected. FDG PET/CT was limited in the spatial resolution of 5 mm and low FDG-avid disease. To be evaluation of the interval change of metabolic response before and after radiotherapy of thoracic malignancies, we plan to initiate a prospective study trail the takes advantages of recent technical advances of technique in 4-dimensional PET/CT (4-D PET/CT) with respiratory gating system.
Respiratory motion creates artifacts in PET and PET/CT images, and can alter diagnosis. The tumor edge would be blurred due to respiratory movement, and be underestimated the uptake value. Also, semi-quantitative measurement, standard uptake value (SUV), combined with parameters such as the lesion site and shape, which is commonly used to make the final assessment of disease would be mis-estimated.
The study aims to investigate the correlation of 4-D PET/CT with respiratory gating methods and free breathing PET/CT when processing primary thoracic malignancy and normal tissue effect.
Detailed description
Radiation pneumonitis is the dose-limiting toxicity in thoracic radiotherapy (RT) for thoracic malignancy. It occurs beginning after the initiation of RT for up to 6 months characterized by cough, shortness of breath, and changes in lung function. A mortality rate approaches 50% in severe radiation pneumonitis [4]. Dosimetric parameters, such as the percentage of lung volume irradiated ≧20 Gy (V20) and the mean lung dose (MLD), provide a guide to assess the risk of radiation pneumonitis in the treatment planning process. However, the parameters have poor predictive power for individual risk. The appearance of radiation lung injury shown in computed tomography (CT) was characterized by and early and a late phase. Since, radiation pneumonitis is characterized by the migration of leukocytes from the blood to irradiated lung tissue; thus, on FDG-PET imaging, more intense inflammatory responses will result in greater FDG uptake. Identifying an early sign or precursor of normal tissue damage helps predicting the delayed organ dysfunction.
In combined PET/CT, CT is used for localization and correction for attenuation in the PET images. An accurate spatial registration of PET and CT image sets is a prerequisite for accurate diagnosis and SUV measurement. However, because of respiration, and the difference in the acquisition time required to image the thorax between PET (6-9 minutes) and CT (~15 seconds), spatial misalignment between the 2 image sets is not uncommon. This misalignment significantly compromises the interpretation of PET images, resulting in mislocalization of the lesion and inaccurate quantitation of the SUV. The main cause of these artifacts is the dynamic interaction between transaxial image acquisition and the asynchronous motion of tumor and normal tissues. To account for motion effects, respiratory gating techniques have been developed.
A more sophisticated respiratory-motion monitoring system is the Real-Time Position Management respiratory gating system (RPM). The system includes a video camera that measures respiratory motion by tracking the vertical displacement of 2 infrared reflective markers rigidly mounted on a plastic block placed on the patient's thorax. The motion of the block is displayed by a graphical interface on the RPM workstation. It has been used in gated radiotherapy of lung, respiratory-gated CT, and 4-D CT, as well as respiratory-gated PET imaging.
We plan to enroll patients with thoracic cancer who scheduled further radiotherapy. Patients with pre-existing chronic lung disease, such as COPD, interstitial lung disease, cystic lung disease, et al, will be excluded. The FDG PET/CT will be performed before the radiotherapy (baseline study), and 30-45 days after completing radiotherapy (2nd study). Free-breathing whole body scan will be performed after 40 minutes, and regional 4D PET/CT with RPM method for chest was performed subsequently. These patients will be follow-up in radiation oncology clinics, any radiation-related adverse effect and long-term prognosis will be recorded. The association between the data analysis will be further investigated.
We will obtain better delineation of the correlation and the differences between free-breathing PET/CT 4-D PET/CT with RPM respiratory-gating methods in processing tumor metabolism, more over, to assess normal tissue metabolic effect. And the further work is trying to find if the application helps in clinical outcomes and prediction of prognosis of the technique of 4-D PET/CT with RPM respiratory-gating methods.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thoracic cancer who will be scheduled further radiotherapy
Key inclusion criteria (2 listed)
- Patients with thoracic cancer who will be scheduled further radiotherapy.
- Aged 20-80 years old.
Key exclusion criteria (3 listed)
- Pre-existing chronic lung disease, such as COPD, interstitial lung disease, cystic lung disease, et al.
- Pregnancy.
- Any medical contraindication of FDG PET study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
normal tissue effect
Time frame: Dec, 2014
The patient should be fasting prior to the exam for at least 6 hours. Before the radiopharmaceutical injection, we will take a sample of blood from a vein to test the blood sugar level. High levels of circulating glucose essentially compete with radioactive FDG in the exam, and image degradation may occur. Then F-18 FDG PET/CT study with 10 mCi tracer was injected from vein. All PET/CT studies were performed on the hybrid PET/CT scanner (Discovery VCT, General Electric Medical Systems).After uptake time of 60 minutes, whole body FDG PET from the vertex of the skull to the proximal thighs in 3D mode at 60 minutes after intravenous administration of FDG. After 60 minutes of the first imaging, delayed 4-D PET/CT with RPM respiratory gating method will be applied to lung fields. The time-points of FDG PET/CT are before radiotherapy (baseline study), and 30-45 days after completing radiotherapy (2nd study).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
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.
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 To Correlate RPM Respiratory-gating Methods Analyses, Treatment Response, and Normal Tissue Metabolic Effect. and Application in Clinical Outcomes and Prediction of Prognosis., 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 14 Feb 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?
normal tissue effect (time frame: Dec, 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2014.