Clinical trial · Interventional
Non-contrast MR Imaging for Whole Body Cancer Detection and Characterization
NCT03440554CI-TRIAL-00051429unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to learn how to improve MRIs (Magnetic Resonance Imaging) that do not require the patient to be injected with a contrast dye. Researchers expect to learn how to better find and describe tumors in patients with prostate cancer. Participants have a whole body research MRI scan within 90 days of a standard-of-care imaging procedure. The research study will collect copies of those scans to compare to the research scans as part of the study analysis. Patients who have additional standard-of-care scans within 12 months after their research scan may be asked to have a second non-contrast MRI for research within 90 days of their follow-up standard of care imaging. The whole body MRI scan will be compared to the standard-of-care scan for prostate cancer detection and to assess patient response to standard-of-care treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Whole Body Non-Contrast MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Whole Body Non-Contrast MRI
- interventionNames
- Diagnostic Test: Whole Body Non-Contrast MRI
Primary outcomes (2)
- measure
- Specificity and Sensitivity of Whole Body MRI in Relation to Standard-of-Care Imaging
- timeFrame
- 15 months
- description
- Paired t-test
- measure
- Covariance of Whole Body MRI Cellularity Index (CI) and PET/CT Standardized Uptake Value (SUV)
- timeFrame
- 15 months
- description
- For each identified lesion in the PET/CT, the lesion will be outlined, the size measured in millimeters, and the SUV will be calculated using the following equation: SUV= (decay-(corrected activity (kBq))/(tissue volume (ml) ))/(injected=(FDG activity (kBq))/(body weight (g) )) Baseline SUVs will also be calculated within normal appearing tissue. Similarly, for each identified lesion in the whole-body RSI-MRI, the lesion will be outlined, the size measured as indicated above, and the CI will be calculated. Baseline CIs will also be calculated within normal appearing tissue. The quantitative data will be analyzed for correlation across all lesions in all patients to determine the degree to which PET/CT SUV values and RSI-MRI CI values co-vary. Significance of the correlation coefficient, compared to zero correlation, will be assessed via the Student t-test, with alpha set to 0.05.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have known or suspected genitourinary metastatic disease and have already had or will have a CT, PET/CT, bone scan or MRI with contrast. * Age ≥ 18 years. * ECOG performance status 0-3. * Capacity to give informed consent. * Ability to lay supine for 30-60 minutes * Ability to hear adequately without hearing aids. Exclusion Criteria: * Patients with medical implants/devices or indwelling foreign material considered unsafe for MRI scanning will be excluded. Safety of medical implants/devices will be determined by the current UC San Diego Radiology and Imaging Services MRI safety policy. The name, manufacturer, and model number of any medical implant/device contained within a potential study subject will be obtained and reviewed to determine safety. Patients will be excluded if any implant/device is found to be unsafe for MRI scanning. * Patients may be excluded if their weight exceeds 350 lbs, the limit for the safe operation of the MRI scanning table. * A patient who is pregnant or trying to become pregnant will be excluded. * Patients with any other condition that, in the opinion of the investigator, may deem them ineligible for study participation.
References
Publications (13)
- BACKGROUNDMarusyk A, Almendro V, Polyak K. Intra-tumour heterogeneity: a looking glass for cancer? Nat Rev Cancer. 2012 Apr 19;12(5):323-34. doi: 10.1038/nrc3261. PMID 22513401
- BACKGROUNDJacobs EL, Haskell CM. Clinical use of tumor markers in oncology. Curr Probl Cancer. 1991 Nov-Dec;15(6):299-360. doi: 10.1016/0147-0272(91)90005-u. PMID 1760927
- BACKGROUNDDrukteinis JS, Mooney BP, Flowers CI, Gatenby RA. Beyond mammography: new frontiers in breast cancer screening. Am J Med. 2013 Jun;126(6):472-9. doi: 10.1016/j.amjmed.2012.11.025. Epub 2013 Apr 3. PMID 23561631
- BACKGROUNDFischer AH. The diagnostic pathology of the nuclear envelope in human cancers. Adv Exp Med Biol. 2014;773:49-75. doi: 10.1007/978-1-4899-8032-8_3. PMID 24563343
- BACKGROUNDWhite NS, McDonald C, Farid N, Kuperman J, Karow D, Schenker-Ahmed NM, Bartsch H, Rakow-Penner R, Holland D, Shabaik A, Bjornerud A, Hope T, Hattangadi-Gluth J, Liss M, Parsons JK, Chen CC, Raman S, Margolis D, Reiter RE, Marks L, Kesari S, Mundt AJ, Kane CJ, Carter BS, Bradley WG, Dale AM. Diffusion-weighted imaging in cancer: physical foundations and applications of restriction spectrum imaging. Cancer Res. 2014 Sep 1;74(17):4638-52. doi: 10.1158/0008-5472.CAN-13-3534. PMID 25183788
- BACKGROUNDAttariwala R, Picker W. Whole body MRI: improved lesion detection and characterization with diffusion weighted techniques. J Magn Reson Imaging. 2013 Aug;38(2):253-68. doi: 10.1002/jmri.24285. PMID 23960006
- BACKGROUNDWhite NS, Dale AM. Distinct effects of nuclear volume fraction and cell diameter on high b-value diffusion MRI contrast in tumors. Magn Reson Med. 2014 Nov;72(5):1435-43. doi: 10.1002/mrm.25039. Epub 2013 Dec 19. PMID 24357182