Characterize Tumor Hypoxia by Magnetic Resonance Imaging
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|ClinicalTrials.gov Identifier: NCT03987568|
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : September 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Prostate Tumor||Other: Blood draws Diagnostic Test: Magnetic resonance imaging (MRI)||Not Applicable|
- To assess hypoxia in primary prostate tumors by magnetic resonance imaging.
- To correlate hypoxic score with disease aggressiveness (proliferation biomarkers' expression).
- To correlate hypoxic score with ExoHypoxic concentration in plasma of same patient.
- To correlate hypoxic score with fatty acid synthase (FASN) expression.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||To Characterize Tumor Hypoxia by Magnetic Resonance Imaging in African American and Caucasian Prostate Cancer Patients|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||October 2021|
Experimental: Diagnostic (MRI biospecimen collection)
Patients undergo MRI over 15 minutes before standard of care surgery. Patients also undergo collection of blood samples during MRI and at the time of surgery.
Other: Blood draws
Blood draws at two specified timepoints - the first is during the MRI and the second is scheduled during participant's prostatectomy.
Diagnostic Test: Magnetic resonance imaging (MRI)
At the beginning of study magnetic resonance imaging MRI will be completed.
- Differences in Tumor Hypoxia Scores Between Subgroups [ Time Frame: 30 days ]Using MRI parameters including apparent diffusion coefficient and fractional blood value four race/score combination groups (African-Americans with Gleason score 6; African-Americans with Gleason score greater than or equal to 7; Caucasians with Gleason score 6; and Caucasian with Gleason score greater than or equal to 7) to calculate the correlation coefficients estimates between hypoxic scores using Pearson correlation coefficient and Spearman's rank correlation coefficient.
- Number of Biomarkers Expressed [ Time Frame: 30 days ]Expression of proliferation biomarkers (Ki-67 and PCNA) to calculate the correlation coefficients estimates between expression of proliferation biomarkers using Pearson correlation coefficient and Spearman's rank correlation coefficient.
- ExoHypoxic Concentrations in Plasma [ Time Frame: 30 days ]The associations between hypoxic score and candidate biomarkers for ExoHypoxic concentration (number per milliliter plasma) will be estimated using partial Spearman's rank correlation coefficient where the race/score combination groups are adjusted.
- Number of Fatty Acid Synthase Expressions in Prostate Cancer and ExoHypoxic Concentrations [ Time Frame: 30 days ]The associations between hypoxic score and fatty acid synthase expression will be estimated using partial Spearman's rank correlation coefficient where the race/score combination groups are adjusted.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987568
|Contact: Jennifer Thomas, RNfirstname.lastname@example.org|
|United States, North Carolina|
|Wake Forest Baptist Comprehensive Cancer Center||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Jennifer Thomas, RN|
|Principal Investigator:||Gagan Dee[, Ph.D||Wake Forest University Health Sciences|