Non-contrast MR Imaging for Whole Body Cancer Detection and Characterization

Prostate Cancer Clinical Trial

Official title:

Non-contrast MR Imaging for Whole Body Cancer Detection and Characterization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03440554
• Other study ID #: 151686
• Status: Recruiting
• Phase: N/A
• Start date: March 24, 2016
• Est. completion date: January 1, 2023

Study information

• Verified date: April 2021
• Source: University of California, San Diego
• Contact: Candace Winkler, MS
• Phone: 8588225398
• Email: cmwinkler[@]ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Participants will undergo a whole body non-contrast MRI study with a whole-body protocol incorporating routine clinical sequences as well as non-contrast research sequences. The patient will also undergo clinically indicated standard-of-care imaging such as PET/CT, CT, Technetium-99m bone scan or MRI with contrast as determined by the patient's oncologist. When the standard-of-care imaging has not yet been performed upon enrollment, the research MRI will ideally be performed on the same day as the standard-of-care exam. However, scheduling constraints and patient time constraints may preclude scheduling both scans on the same day. In this case, the scans will be performed within a week 90 days of each other. An experienced radiologist will read both scans and results will be provided to the patient's oncologist for clinical follow up. Patients receiving additional standard-of-care imaging within 12 months after the research MRI may be asked to return for an additional whole body MRI scan within 90 days of their standard-of-care scan. The additional research scan will be requested of patients that have evidence of progression during ongoing standard of care treatment and monitoring. The additional scan would be requested of those patients to compare baseline scans to those that are completed during standard of care imaging. This would be an additional tool to verify disease progression or treatment response.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 1, 2023
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Whole Body Non-Contrast MRI
Whole Body Non-Contrast MRI in Prostate Cancer Patients

Locations

Country	Name	City	State
United States	UC San Diego Moores Cancer Center	La Jolla	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	Prostate Cancer Foundation, United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (12)

Attariwala 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. Review. — View Citation

Drukteinis 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. Review. — View Citation

Fischer 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. Review. — View Citation

Jacobs EL, Haskell CM. Clinical use of tumor markers in oncology. Curr Probl Cancer. 1991 Nov-Dec;15(6):299-360. Review. — View Citation

Liss MA, White NS, Parsons JK, Schenker-Ahmed NM, Rakow-Penner R, Kuperman JM, Bartsch H, Choi HW, Mattrey RF, Bradley WG, Shabaik A, Huang J, Margolis DJ, Raman SS, Marks LS, Kane CJ, Reiter RE, Dale AM, Karow DS. MRI-Derived Restriction Spectrum Imaging Cellularity Index is Associated with High Grade Prostate Cancer on Radical Prostatectomy Specimens. Front Oncol. 2015 Feb 17;5:30. doi: 10.3389/fonc.2015.00030. eCollection 2015. — View Citation

Marusyk 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. Review. — View Citation

McCammack KC, Kane CJ, Parsons JK, White NS, Schenker-Ahmed NM, Kuperman JM, Bartsch H, Desikan RS, Rakow-Penner RA, Adams D, Liss MA, Mattrey RF, Bradley WG, Margolis DJ, Raman SS, Shabaik A, Dale AM, Karow DS. In vivo prostate cancer detection and grading using restriction spectrum imaging-MRI. Prostate Cancer Prostatic Dis. 2016 Jun;19(2):168-73. doi: 10.1038/pcan.2015.61. Epub 2016 Jan 12. — View Citation

Rakow-Penner RA, White NS, Parsons JK, Choi HW, Liss MA, Kuperman JM, Schenker-Ahmed N, Bartsch H, Mattrey RF, Bradley WG, Shabaik A, Huang J, Margolis DJ, Raman SS, Marks L, Kane CJ, Reiter RE, Karow DS, Dale AM. Novel technique for characterizing prostate cancer utilizing MRI restriction spectrum imaging: proof of principle and initial clinical experience with extraprostatic extension. Prostate Cancer Prostatic Dis. 2015 Mar;18(1):81-5. doi: 10.1038/pcan.2014.50. Epub 2015 Jan 6. — View Citation

White 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. — View Citation

White NS, Leergaard TB, D'Arceuil H, Bjaalie JG, Dale AM. Probing tissue microstructure with restriction spectrum imaging: Histological and theoretical validation. Hum Brain Mapp. 2013 Feb;34(2):327-46. doi: 10.1002/hbm.21454. Epub 2012 Jan 16. — View Citation

White NS, McDonald C, Farid N, Kuperman J, Karow D, Schenker-Ahmed NM, Bartsch H, Rakow-Penner R, Holland D, Shabaik A, Bjørnerud 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. Review. Erratum in: Cancer Res. 2014 Nov 15;74(22):6733. McDonald, Carrie R [corrected to McDonald, Carrie];Kaine, Christopher J [corrected to Kane, Christopher J]. — View Citation

White NS, McDonald CR, Farid N, Kuperman JM, Kesari S, Dale AM. Improved conspicuity and delineation of high-grade primary and metastatic brain tumors using "restriction spectrum imaging": quantitative comparison with high B-value DWI and ADC. AJNR Am J Neuroradiol. 2013 May;34(5):958-64, S1. doi: 10.3174/ajnr.A3327. Epub 2012 Nov 8. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity and Sensitivity of Whole Body MRI in Relation to Standard-of-Care Imaging	Paired t-test	15 months
Primary	Covariance of Whole Body MRI Cellularity Index (CI) and PET/CT Standardized Uptake Value (SUV)	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.	15 months