Application in Clinical Outcomes and Prediction of Prognosis. Clinical Trial
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.
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.
| Status | Not yet recruiting |
| Enrollment | 30 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Patients with thoracic cancer who will be scheduled further radiotherapy. - Aged 20-80 years old. Exclusion Criteria: - Pre-existing chronic lung disease, such as COPD, interstitial lung disease, cystic lung disease, et al. - Pregnancy. - Any medical contraindication of FDG PET study. |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Far Eastern Memorial Hospital | New Taipei City |
| Lead Sponsor | Collaborator |
|---|---|
| Far Eastern Memorial Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | Dec, 2014 | No |