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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00375830
First received: September 11, 2006
Last updated: August 5, 2015
Last verified: August 2015
  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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 2019
Estimated Primary Completion Date: December 2018 (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
Criteria

Inclusion Criteria:

  • Patient is ≥ 18 years old at the time of the drug administration
  • Patient provides written informed consent
  • Patient is diagnosed with ≥ stage 3 breast cancer or ≥ stage 2 prostate cancer (and/or PSA >10 micrograms/L), including patient with recurrent breast or prostate cancer
  • Patient is capable of complying with study procedures
  • Patient is able to remain still for duration of imaging procedure (about one hour)

Exclusion Criteria:

  • Patient is < 18 years old at the time of the drug administration
  • Patient is pregnant or nursing
  • Metallic implants (contraindicated for MRI)
  • Renal function impairment preventing administration of MRI contrast
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375830

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Andrei Iagaru    650-725-4711    aiagaru@stanford.edu   
Principal Investigator: Andrei Iagaru         
Sub-Investigator: Eric Mittra         
Sub-Investigator: Shreyas Vasanawala         
Sub-Investigator: Robert Herfkens         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Andrei Iagaru, MD 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: August 5, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 27, 2015