Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Neoplasms
- Lymphoma
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Cancer suspects will undergo standard diagnostic evaluation and novel diagnostic. Single arm.Masking: None (Open Label)Masking Description: No masking, open label.Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Prospective feasibility and validation study of a novel contrast microhalography (CEM) device for diagnosis of malignancy in Botswana. Consenting patients identified by their providers as requiring a fine needle aspirate (FNA) or percutaneous biopsy for assessment for possible lymphoma or breast can...
Prospective feasibility and validation study of a novel contrast microhalography (CEM) device for diagnosis of malignancy in Botswana. Consenting patients identified by their providers as requiring a fine needle aspirate (FNA) or percutaneous biopsy for assessment for possible lymphoma or breast cancer will undergo standard diagnostic procedure. Concurrently these patients will have additional FNA fluid tested using the portable novel nanosensor-based device (CEM). Diagnosis made from standard anatomic pathology, flow cytometry, and/or cytology will be compared with the diagnosis made using the CEM platform. Assessment of the feasibility and acceptability of the CEM platform will be performed. Assessment of training requirements for CEM platform will be completed.
Tracking Information
- NCT #
- NCT04119154
- Collaborators
- National Cancer Institute (NCI)
- Botswana Harvard AIDS Institute Partnership
- Massachusetts General Hospital
- Brigham and Women's Hospital
- Investigators
- Principal Investigator: Ralph Weissleder, MD, PhD Massachusetts General Hospital Principal Investigator: Scott Dryden-Peterson, MD, MSc Botswana Harvard AIDS Institute, Harvard TH Chan School of Public Health, Brigham and Women's Hospital
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