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).
Sponsored Research
Industry and academic studies in which HALO Diagnostics (Indian Wells, CA) served as a participating site.
Completed · NCT05915026
A Phase 3 study of how gadoquatrane, an investigational MRI contrast agent, moves into, through, and out of the body, and how safe it is, in children from birth to under 18 years scheduled for a contrast-enhanced MRI.
Sponsor: Bayer · Bayer study 21196 · Completed September 2024
Completed · NCT05915702
A Phase 3 study comparing how well gadoquatrane works, and its safety, against an already available MRI contrast agent in adults with known or suspected brain or spinal cord-related problems.
Sponsor: Bayer · Bayer study 21181 · Completed May 2024
Completed · NCT05915728
A Phase 3 study comparing how well gadoquatrane works, and its safety, against an already available MRI contrast agent in adults with known or suspected problems of the body outside the brain and spinal cord.
Sponsor: Bayer · Bayer study 21197 · Completed June 2024
Closed · Amyloid PET
A national study of how amyloid PET brain imaging affects the diagnosis and care of Medicare beneficiaries with mild cognitive impairment or dementia of uncertain cause.
Sponsored and managed by the American College of Radiology · Directed by the Alzheimer’s Association
Enrollment Closed · NCT02951598
A longitudinal observational study of health care use, costs, and clinical outcomes over time in amyloid-positive adults with mild cognitive impairment or mild dementia due to Alzheimer’s disease in the United States. No study therapy was given.
Sponsor: Eli Lilly and Company