Application of BOLD Technique in bone metastasis as a powerful Biomarker; Evaluation of treatment effect
- Conditions
- Neoplasms
- Registration Number
- KCT0005134
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 95
Patients older than 18 years old who meet both of the following conditions:
1. Diagnosed to have bone metastasis from lung cancer at lower T-spine (below T7), L-spine, sacrum, pelvic bones, or proximal femur
2. Planning to undergo systemic therapy (chemotherapy or target therapy) for metastatic bone lesion
Patients with any of the following criteria are excluded:
1. Prior surgery or radiation treatment to the metastatic bone lesion
2. Metallic instrumentation state at the metastatic bone lesion
3. History of previous systemic therapy for lung cancer
4. Contraindication to MRI contrast material, including renal failure (glomerular filtration rate [GFR] less than 30, within 2 months prior to MRI examination), moderate or severe adverse effect to gadolinium contrast material, or other causes
5. Patients who are unsuitable for MRI, such as claustrophobia or poor cooperation due to severe pain
6. Pregnancy or nursing state
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent change of tumor T2* relaxivity constant (R2*) after systemic therapy (?R2*%)
- Secondary Outcome Measures
Name Time Method Percent change of tumor volume, apparent diffusion coefficient (ADC), volume transfer constant (Ktrans), constant rate (Kep), blood plasma volume (Vp), volume fraction of the extravascular extracellular matrix (Ve), proton density fat fraction (PDFF), maximum standardized uptake value (SUVmax) after systemic therapy;Local tumor progression;Local progression-free survival