Skip to main content
OpenTrials
Completed

NCT Number: NCT02064283

Early Assessment of Treatment Response Using Functional Diffusion Mapping

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diffusion MRI

Procedure

Primary outcomes

  1. Change in diffusion MRI measurements

    Time frame: Baseline, 2 weeks and 9-12 weeks

    Identify changes in Diffusion Magnetic Resonance Imaging (MRI) measurements and correlate the changes with response to therapy.

Secondary outcomes

  1. Change in units/L of CK18Asp306

    Time frame: Baseline, 2 weeks and 9-12 weeks

    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.

  2. Change in levels of bone turnover markers

    Time frame: Baseline, 2 weeks and 9-12 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Feb 17, 2014
Registry last updated
Dec 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.