Early Assessment of Treatment Response Using Functional Diffusion Mapping

Prostate Cancer Clinical Trial

Official title:

Early Assessment of Treatment Response Using Functional Diffusion Mapping

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064283
• Other study ID #: UMCC 2006.111
• Secondary ID: HUM00009498
• Status: Completed
• Phase: N/A
• First received: February 13, 2014
• Last updated: December 8, 2014
• Start date: May 2007
• Est. completion date: October 2012

Study information

• Verified date: December 2014
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Procedure:
• Diffusion MRI

Locations

Country	Name	City	State
United States	The University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in diffusion MRI measurements	Identify changes in Diffusion Magnetic Resonance Imaging (MRI) measurements and correlate the changes with response to therapy.	Baseline, 2 weeks and 9-12 weeks	No
Secondary	Change in units/L of CK18Asp306	Levels of CK18Asp396 can be measured in serum using a commercially available ELISA (Enzyme-linked Immunosorbent Assay). Changes in serum CK18Asp396 (a marker of apoptosis) will be correlated with functional diffusion maps and treatment response.	Baseline, 2 weeks and 9-12 weeks	No
Secondary	Change in levels of bone turnover markers	Correlate the changes in biochemical markers of bone turnover, such as N-telopeptide and bone-specific alkaline phosphatase, with functional diffusion maps and treatment response.	Baseline, 2 weeks and 9-12 weeks	No