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Enhancing SUV Accuracy of PET/MR for Clinical Trial Qualification

NCT03603925 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 37

Last updated 2021-11-05

No results posted yet for this study

Summary

Standardized Uptake Values (SUVs), normalized activity concentration, measured using PET/MR have inaccuracies ≥ 20% which exceeds National Cancer Institute / American College of Radiology Imaging Network (NCI/ACRIN), Radiological Society of North America / Quantitative Imaging Biomarkers Alliance (RSNA/QIBA) specifications and disqualifies PET/MR from multicenter or cooperative group clinical trials. High inaccuracy is primarily due to poor attenuation correction (AC) owing to lack of computed tomography (CT) data. This study will develop acquisition and analyses methods to synthesize CT images from MR data that can be used to achieve SUVs that are within 5% of those obtained using PET/CT (reference standard), thus meeting accuracy requirements needed to qualify for multicenter trials.

The overall goal of this research project is to validate clinically practical methods for producing MR-based attenuation correction information which is needed to produce quantitatively accurate PET images from a PET/MR scanner. Existing commercial PET/MR systems use methods that are inaccurate.

Conditions

  • Positron Emission Tomography-Magnetic Resonance (PET-MR)

Interventions

DIAGNOSTIC_TEST

Positron Emission Test / Magnetic Resonance (PET/MR)

The Philips Ingenuity PET/MR is used for research scanning. Patients receiving a clinically indicated PET/CT, will be approached to be included in this study. There is no special preparation other than that needed for the prerequisite PET/CT scanning. At the completion of the PET/CT scanning, the subject will be taken to the PET/MR scanner, which is in close in proximity, for research scanning. The research scanning would take up to one hour or as tolerated.

DIAGNOSTIC_TEST

Positron Emission Test / Computed Tomography (PET/CT)

Patients will receive PET / CT imaging for the detection of cancer or other clinically indicated anomalies. The completed study visit is expected to take approximately 2 hours and not longer than 3 hours.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Raymond F. Muzic, PhD · University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-17
Primary Completion
2021-04-07
Completion
2021-04-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03603925 on ClinicalTrials.gov