Positron Emission Tomography-Magnetic Resonance (PET-MR) Clinical Trial
Official title:
Enhancing SUV Accuracy of PET/MR for Clinical Trial Qualification
| Verified date | October 2021 |
| Source | Case Comprehensive Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 37 |
| Est. completion date | April 7, 2021 |
| Est. primary completion date | April 7, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Receiving PET/CT at University Hospitals Cleveland Medical Center (UHCMC) for a clinical indication - No Contraindications to undergo MR as assessed using University Hospitals (UH) Radiology standard MR assessment form - Has the ability to understand and willingness to sign a written informed consent - The circumference of the volunteer in the body section, as determined using a measuring tape, to be scanned must be less than or equal to 110 cm to avoid field of view limitations on the PET/MR Exclusion Criteria: - Patient size or circumference greater than the MR gantry of the PET/MR. - Pregnancy or lactation. - Contraindications to undergo MR as assessed using UH Radiology standard MR assessment form. - Claustrophobia or inability to tolerate MR examination (lay still for approximately 1 hour and hold breath intermittently). - Individuals who are not willing or capable of giving informed consent or assent (with legal guardian consent). |
| Country | Name | City | State |
|---|---|---|---|
| United States | University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Case Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Quantitative agreement between measured CT and CT synthesized from MR data (Hounsfield Units) | Demonstrate quantitative agreement between measured CT and CT synthesized from MR data | Up to 3 hours after beginning scan | |
| Primary | Quantitative agreement in the derived linear attenuation coefficients at 511 kilo electro volts (keV). | Demonstrate quantitative agreement in the derived linear attenuation coefficients at 511 keV. | Up to 3 hours after beginning scan | |
| Secondary | Percent difference in Standardized Uptake Values (SUVs) in PET/CT scans compared to PET/MR scans | Demonstrate that SUVs in lesions and normal tissues measured using MR-based attenuation correction (MR-AC) are within 5% of those measured using PET/CT. | Up to 3 hours after beginning scan |