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PET/CT and Whole-Body MRI for Detection of Skeletal and Soft Tissue Metastases


N/A
18 Years
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

PET/CT and Whole-Body MRI for Detection of Skeletal and Soft Tissue Metastases


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Sanjiv Sam Gambhir M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

BONE0001

NCT ID:

NCT00375830

Start Date:

January 2006

Completion Date:

December 2015

Related Keywords:

  • Cancer
  • Neoplasm Metastasis

Name

Location

Stanford University School of MedicineStanford, California  94305-5317