Early Assessment of Treatment Response Using Functional Diffusion Mapping

NCT ID: NCT02064283

Last Updated: 2014-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2012-10-31

Brief Summary

This study will evaluate the feasibility of identifying changes in diffusion MRI characteristics of bone that correlates with response to therapy in men with metastatic prostate cancer.

Detailed Description

This study will evaluate a special type of MRI (magnetic resonance imaging) scan that measures the movement of water molecules through tissue called diffusion MRI. Researchers are using this new MRI technology to track the diffusion, or movement, of water through tumor tissue, and map these changes as a cancer patient undergoes treatment. Early research seems to indicate that tumor cells restrict the movement of water, so as tumor cells die, the movement of water changes within the tumor. These changes in the movement (diffusion) of water may help doctors determine earlier than traditional tests whether a patient's cancer is responding (getting better) to treatment. This study will evaluate the feasibility of identifying changes in diffusion MRI characteristics of bone that correlates with response to therapy in men with metastatic prostate cancer.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Diffusion MRI Assessment

Men with newly diagnosed metastatic disease initiating therapy with androgen deprivation, or men with hormone refractory prostate cancer initiating treatment with chemotherapy, will be assessed by diffusion MRI (Magnetic Resonance Imaging) at baseline, 2 weeks and again at 9-12 weeks.

Group Type: EXPERIMENTAL

Diffusion MRI

Intervention Type: PROCEDURE

Interventions

Diffusion MRI

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of prostate cancer.
• Evidence of metastatic disease by bone scan.
• Patients must be initiating systemic therapy for metastatic disease.
• New D2 disease beginning therapy with androgen deprivation.
• CRPC (Castration Resistant Prostate Cancer) beginning systemic non hormonal therapy.
• Patients must be willing to provide the blood samples for the correlative markers.
• Patients must be able to lie flat in an MRI (Magnetic Resonance Imaging) magnet for 30-60 minutes.
• Life expectancy of 12 weeks or greater.
• All patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria

• Contraindication to MRI imaging.
• Patients who require sedation with general anesthesia to undergo MRI imaging.
• Weight greater than 275 pounds.

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maha Hussain, MD, FACP

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

References

Brisset JC, Hoff BA, Chenevert TL, Jacobson JA, Boes JL, Galban S, Rehemtulla A, Johnson TD, Pienta KJ, Galban CJ, Meyer CR, Schakel T, Nicolay K, Alva AS, Hussain M, Ross BD. Integrated multimodal imaging of dynamic bone-tumor alterations associated with metastatic prostate cancer. PLoS One. 2015 Apr 10;10(4):e0123877. doi: 10.1371/journal.pone.0123877. eCollection 2015.

Reference Type: DERIVED

PMID: 25859981 (View on PubMed)

Other Identifiers

HUM00009498

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2006.111

Identifier Type: -

Identifier Source: org_study_id