Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza)

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.

Inclusion criteria

• Botswana citizen
• Age 18 years or older
• Able and willing to provide informed consent
• Undergoing diagnostic procedure for palpable abnormality (biopsy, node/mass resection, or fine-needle aspirate) for diagnosis of possible lymphoid malignancy or breast cancer

Exclusion criteria

• Involuntary incarceration (prison, jail, etc.)
• Procedures involving internal organs or locations expected to have elevated risk of complication
• Increased risk for severe bleeding as defined as known hemophilia or other bleeding disorder, use of anticoagulants in past week (not including aspirin or other NSAIDS), advanced liver disease, or other condition determined by clinician to significantly increase bleeding risk of procedure
• Known pregnancy
• Critical illness as defined by current intensive care admission, hypotension (systolic BP<100mmHg), hypoxemia (O2 saturation <94% on room air), or other condition determined by clinician to significantly decrease physiologic tolerance of procedure
• Other condition felt by the clinician performing procedure to significantly increase risk of procedure