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

NCT ID: NCT03440554

Last Updated: 2021-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-24
• Study Completion Date: 2023-01-01

Brief 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.

Detailed 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Whole Body Non-Contrast MRI

Group Type: EXPERIMENTAL

Whole Body Non-Contrast MRI

Intervention Type: DIAGNOSTIC_TEST

Whole Body Non-Contrast MRI in Prostate Cancer Patients

Interventions

Whole Body Non-Contrast MRI

Whole Body Non-Contrast MRI in Prostate Cancer Patients

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Prostate Cancer Foundation

OTHER

Sponsor Role: collaborator

United States Department of Defense

FED

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Michael Hahn

Assistant Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael E Hahn, MD

Role: PRINCIPAL_INVESTIGATOR

UC San Diego Moores Cancer Center

Locations

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Candace Winkler, MS

Role: CONTACT

cmwinkler@ucsd.edu

8588225398

Michael E Hahn, MD

Role: CONTACT

mehahn@ucsd.edu

(619)543-6641

Facility Contacts

Candace M Winkler, MS

Role: primary

cmwinkler@ucsd.edu

858-822-5398

Christopher Sera

Role: backup

chsera@ucsd.edu

8585344822

References

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.

Reference Type: BACKGROUND

PMID: 22513401 (View on PubMed)

Jacobs 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.

Reference Type: BACKGROUND

PMID: 1760927 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23561631 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24563343 (View on PubMed)

White 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.

Reference Type: BACKGROUND

PMID: 25183788 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23960006 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24357182 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23169482 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25559097 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23139079 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25741473 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26754261 (View on PubMed)

Conlin CC, Feng CH, Digma LA, Rodriguez-Soto AE, Kuperman JM, Rakow-Penner R, Karow DS, White NS, Seibert TM, Hahn ME, Dale AM. A Multicompartmental Diffusion Model for Improved Assessment of Whole-Body Diffusion-weighted Imaging Data and Evaluation of Prostate Cancer Bone Metastases. Radiol Imaging Cancer. 2023 Jan;5(1):e210115. doi: 10.1148/rycan.210115.

Reference Type: DERIVED

PMID: 36705559 (View on PubMed)

Other Identifiers

151686

Identifier Type: -

Identifier Source: org_study_id