Actively Recruiting
Phase I Human Analytics (HALO) Study
Led by HALO Diagnostics · Updated on 2022-10-14
2000
Participants Needed
1
Research Sites
780 weeks
Total Duration
On this page
Sponsors
H
HALO Diagnostics
Lead Sponsor
H
HALO Affiliate Sites
Collaborating Sponsor
AI-Summary
What this Trial Is About
Discover, optimize, standardize, and validate clinical-trial measures and biomarkers used to diagnose and differentiate cardiovascular, oncologic, neurologic, and other diseases and disorders. Specifically, our research study endeavors to improve disease and disorder diagnosis to the earliest clinical states, in preclinical states, and to develop ensemble multivariate biomarker risk scores leading to cardiovascular, oncologic, neurologic, and other diseases and disorders. Additionally, the study aims to: * Evaluate data analysis techniques to improve diagnostic accuracy and reduce time to diagnosis. * Evaluate data analysis techniques to improve risk stratification for participants through machine learning algorithms. * Direct participants to relevant and applicable clinical trials.
CONDITIONS
Official Title
Phase I Human Analytics (HALO) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, 45 years of age or older
- Diagnosis of prostate adenocarcinoma
- Clinical stage T1c or T2a
- Gleason score of 7 (3+4 or 4+3) or less
- Three or fewer biopsy cores with prostate cancer
- PSA density not exceeding 0.375
- One, two, or three tumor suspicious regions identified on multiparametric MRI
- Negative radiographic indication of extra-capsular extent
- Karnofsky performance status of at least 70
- Estimated survival of 5 years or greater, as determined by treating physician
- Tolerance for anesthesia/sedation
- Ability to give informed consent
- At least 6 weeks since any previous prostate biopsy
- MR-guided biopsy confirmation of one or more MRI-visible prostate lesion(s) with Gleason score of 7 (3+4 or 4+3) or less
- Salvage candidates accepted upon physician referral
You will not qualify if you...
- Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI
- Severe lower urinary tract symptoms with International Prostate Symptom Score (IPSS) of 20 or greater
- History of other primary non-skin malignancy within previous three years
- Diabetes
- Smoker
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Desert Medical Imaging
Indian Wells, California, United States, 92210
Actively Recruiting
Research Team
C
Christopher R Hancock, MD,MBA
CONTACT
E
Erik W Peterson
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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