Phase I Human Analytics (HALO) Study
About this study
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.
- Condition
- Cardiovascular Diseases, Cancer, Dementia, Traumatic Brain Injury
- Tested
- no interventions will be performed (observational)
- Sponsor
- HALO Diagnostics
Who can join
- Age
- 45 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 20
- Minimum age: 45 years
- Maximum age: 90 years
- Eligible sex: Male
- Study condition: Cardiovascular Diseases, Cancer, Dementia, Traumatic Brain Injury
- Treatment Naïve patients:
- 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 will be accepted upon physician referral.
Exclusion 5
- Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
- Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater
- History of other primary non-skin malignancy within previous three years.
- Diabetes
- Smoker
Where
1 site, 1 recruiting
Desert Medical Imaging
Indian Wells, California, United States
Contact
-
Christopher R Hancock, MD,MBA
760-776-8989 chris.hancock@halodx.com
-
Erik W Peterson
414-745-5773 ERIK.PETERSON@HALODX.COM
Potential match only. Final eligibility is determined by the study team.