Active Research
International experts agree that most novel diagnostic and therapeutic techniques remain investigational and should be performed under an IRB-approved protocol and/or contribute to an IRB-approved registry – the HALO way. Below are HALO’s active and completed clinical trials, and related peer-reviewed publications.
Recruiting · NCT06112418
A randomized, multi-center trial comparing the Cleerly Coronary Artery Disease (CAD) Staging System — which visualizes and quantifies coronary atherosclerosis — against traditional risk factor-based care for the primary prevention of cardiovascular events in patients with type 2 diabetes, prediabetes, or metabolic syndrome.
HALO Diagnostics (Indian Wells, CA) is a participating site, with Dr. John F. Feller as site contact. Sponsored by Cleerly, Inc. in collaboration with CPC Clinical Research; estimated enrollment of 7,500 patients nationwide.
Recruiting · NCT05423860
An observational study analyzing available biomarkers and determinants of health to increase diagnostic accuracy while reducing the time to diagnosis of disease. Sponsored by HALO Diagnostics.
Location: Desert Medical Imaging, Indian Wells, CA. Principal Investigator: Christopher R. Hancock, MD, MBA. Sub-Investigator: Bernadette M. Greenwood, MSc. Study Director: Erik W. Peterson.
Completed · NCT03373006
A Phase II study evaluating Axumin (fluciclovine F 18) PET/CT to assess for metastatic disease in men undergoing laser focal therapy, helping determine which patients are appropriate candidates for a focal therapy cohort. Sponsored by HALO Diagnostics.
Location: Desert Medical Imaging, Indian Wells, CA. Enrollment: 20 participants. Principal Investigator: John F. Feller, MD. Study Director: Bernadette M. Greenwood, MSc.
Long-term follow-up · NCT02243033
A 20-year observational study evaluating outpatient MRI-guided laser focal therapy in men 45–90 with biopsy-confirmed, localized prostate cancer. Sponsored by HALO Diagnostics.
Location: Desert Medical Imaging, Indian Wells, CA. Principal Investigator: John F. Feller, MD. Study Director: Bernadette M. Greenwood, MSc.
van Luijtelaar A, Greenwood BM, Ahmed HU, et al. Focal laser ablation as clinical treatment of prostate cancer: report from a Delphi consensus project. World J Urol. 2019;37(10):2147–2153. doi:10.1007/s00345-019-02636-7
Completed · Historical Feasibility Study
An early feasibility study that generated initial in-vivo ultrasound images to assess the prototype device’s capability for clinical medical imaging and to provide insight into the in-vivo performance of a potential lower-cost ultrasound device.
Historical imaging research · Conducted in Indian Wells, California
Sponsor: Butterfly Network, Inc. · NEIRB approval: August 19, 2018
Published Phase I Research · ISRCTN10201650
John F. Feller, MD and Bernadette M. Greenwood coauthored a first-in-human Phase I study investigating TK-positive oncolytic vaccinia virus delivered using autologous adipose stromal vascular fraction cells in people with advanced solid tumors or acute myeloid leukemia. The published early-phase study assessed feasibility and tolerability and supported additional research.
Minev BR, Lander E, Feller JF, et al. First-in-human study of TK-positive oncolytic vaccinia virus delivered by adipose stromal vascular fraction cells. J Transl Med. 2019;17(1):271. doi:10.1186/s12967-019-2011-3. Sponsored by Calidi Biotherapeutics; registered as ISRCTN10201650 (not ClinicalTrials.gov).
Research Collaborations
HALO Precision Diagnostics has announced participation in Bayer’s Phase III QUANTI clinical-development program evaluating gadoquatrane, an investigational MRI contrast agent. Individual study details, site availability, and enrollment status vary by protocol.
Protocol-specific study information will be added as verified.