PET/CT and Whole-Body MRI for Detection of Skeletal and Soft Tissue Metastases
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Purpose
Fluorine-18 Fluorodeoxyglucose (F-18 FDG) PET/CT is established as a powerful imaging tool for cancer detection and monitoring response to therapy. However, not all cancers are identified reliably due to variable rates of glucose metabolism. Whole-body MRI emerges currently as an excellent modality for morphological characterization of soft tissue and skeletal lesions. Sodium Fluorine-18 (F-18) was used in the 1970's for bone scanning and can be used as a skeletal tracer in current PET/CT scanners. The direct comparison of F-18/F-18 FDG PET/CT and whole-body MRI for skeletal metastases detection was not attempted to date. However, such an approach has the potential to improve cancer diagnosis, staging, prognosis, and therapy monitoring. The combination of these technologies may also allow for improved screening or earlier cancer detection. We will attempt a pilot study with 10 patients to acquire the preliminary results needed to proceed with additional 90 subjects.
| Condition | Intervention |
|---|---|
|
Cancer |
Procedure: F-18 NaF/F-18 FDG PET/CT Procedure: Whole-body MRI Procedure: Tc-99m MDP bone scan |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | PET/CT and Whole-Body MRI for Detection of Skeletal and Soft Tissue Metastases |
- Testing the hypothesis that the adjunctive combination of the F-18/F-18 FDG PET/CT and whole-body MRI provides diagnostic accuracy that is significantly better than Tc-99m bone scanning. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Evaluating F-18 PET/CT as a reliable bone scanning method [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Evaluating skeletal whole-body MRI image repeatability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Evaluating imaging protocol's performance and reliability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PET/CT and Whole-Body MRI |
Procedure: F-18 NaF/F-18 FDG PET/CT
Imaging study to detect cancer
Procedure: Whole-body MRI
Imaging modality to detect cancer
Procedure: Tc-99m MDP bone scan
Imaging modality to evaluate the skeleton
|
Detailed Description:
Fluorine-18 Fluorodeoxyglucose (F-18 FDG) PET/CT is established as a powerful imaging tool for cancer detection and monitoring response to therapy. However, not all cancers are identified reliably due to variable rates of glucose metabolism. Whole-body MRI emerges currently as an excellent modality for morphological characterization of soft tissue and skeletal lesions. Sodium Fluorine-18 (F-18) was used in the 1970's for bone scanning and can be used as a skeletal tracer in current PET/CT scanners. The direct comparison of F-18/F-18 FDG PET/CT and whole-body MRI for skeletal metastases detection was not attempted to date. However, such an approach has the potential to improve cancer diagnosis, staging, prognosis, and therapy monitoring. The combination of these technologies may also allow for improved screening or earlier cancer detection. We will attempt a pilot study with 10 patients to acquire the preliminary results needed to proceed with additional 90 subjects.
The primary objectives include:
Testing the hypothesis that the adjunctive combination of the F-18/F-18 FDG PET/CT and whole-body MRI provides diagnostic accuracy that is significantly better than Tc-99m bone scanning
The secondary objectives include:
- Evaluating F-18 PET/CT as a reliable bone scanning method;
- Evaluating skeletal whole-body MRI image repeatability; and
- Evaluating imaging protocols' performance and reliability.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients older than 18-year-old.
- Patients must have a diagnosis of cancer.
- Patients must understand and voluntarily sign an Informed Consent form after the contents have been fully explained to them.
Exclusion Criteria:
- Patients who cannot complete a PET/CT scan.
- Pregnant women.
- Patients with metallic prosthesis/implants/devices unsafe for MRI imaging.
- Healthy volunteers.
- Patients participating in other research studies.
Contacts and Locations| Contact: Euodia Jonathan | 650 723 7419 | euodia@stanford.edu |
| Contact: Lindee Burton | 650 725 4712 | lburton@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Euodia Jonathan 650-723-7419 euodia@stanford.edu | |
| Contact: Lindee Burton 650 725 4712 lburton@stanford.edu | |
| Sub-Investigator: Sanjiv Gambhir, M.D., Ph.D. | |
| Sub-Investigator: Robert J Herfkens | |
| Principal Investigator: Andrei Iagaru | |
| Sub-Investigator: Shreyas Vasanawala, MD, PhD | |
| Principal Investigator: | Sanjiv Sam Gambhir M.D., Ph.D. | Stanford University |
More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00375830 History of Changes |
| Other Study ID Numbers: | BONE0001, 96754 |
| Study First Received: | September 11, 2006 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013