Use of Electrical Bioimpedance in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Patients (Bioimpedance)

A Pilot Study for the Use of Electrical Bioimpedance in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Patients (Bioimpedance)

The goal of this project is to test non-invasive, painless skin electrical bioimpedance (BioZ) measurements as an adjunctive biomarker to standard bone marrow biopsies.

The goal of this project is to test non-invasive, painless skin electrical bioimpedance (BioZ) measurements as an adjunctive biomarker to standard bone marrow biopsies.

NIH NCI Surveillance, Epidemiology, and End Results Program estimates are that 22,010 new cases of acute myeloid leukemia (AML) will be diagnosed in 2025 with an estimated 11,090 AML-associated deaths, and an estimated 5-year relative survival of 32.9%. Recent progress has led to several new approvals in the first line or relapsed/refractory setting. Treatments usually consist of repeated cycles of chemotherapy, sometimes leading to a stem cell transplant. Yet, despite these advances, cure rates have remained at around 25 - 30%.

The main diagnostic procedure for AML and MDS is a bone marrow aspirate and biopsy (BMBX). The procedure is done using specialized biopsy needles that are pushed in the bone at the level of the posterior iliac crest under local anesthesia. The first step is to aspirate samples of the liquid marrow using a smaller needle. Once the needle is in place, syringes are used to aspirate liquid marrow. The aspiration step is usually uncomfortable irrespective of the level of local anesthesia. The second step of the procedure is to obtain a core biopsy. This is done using a larger needle (Jamshidi needle) that is pushed in the bone at the level of the posterior iliac crest. Once the needle is anchored in the bone, a core of the bone is cut out by rotating the needle over its axis. This is followed by "shaking" motions of the needle to dislodge the core from the bone. The Jamshidi needle is then slowly removed and the core collected for analysis. Samples obtained are analyzed for morphology to estimate bone marrow cellularity and leukemia cell count as well as flow cytometry and molecular diagnostics.

In general, patients have a BMBX at the time of initial diagnosis. Once treatment is started, another BMBX is frequently obtained 2 to 3 weeks after initiation of chemotherapy. A third BMBX is obtained at the time of recovery from the initial treatment cycle. Subsequently, additional BMBX procedures are done to rule out suspected relapses or before proceeding with another line of therapy, such as a bone marrow transplant. BMBX procedures are generally regarded as safe. There is not extensive literature on the incidence and severity of BMBX complications. These include bleeding (that can be serious in leukemic patients with compromised coagulation), infection, and potential nerve damage. A study surveying BMBX procedures in the United Kingdom reported a complication rate of less than 1%, most of which were hemorrhages3. However, in spite of local anesthesia, BMBX procedures can be traumatic and can be associated with significant discomfort with resultant distress to the patient. The procedure can be more traumatic in patients who are overweight or have brittle bones (such as patients with osteoporosis). Frequently, patients have to be put under sedation and have the procedure done under radiologic guidance in order to minimize distress or risks. Consequently, a non-invasive method to evaluate the bone marrow of AML and MDS patients is clearly needed.

Bioimpedance (BioZ) has been reported to be valuable in the detection of various cancers including skin, thyroid, liver, cervix, and breast cancers. Previous studies have shown that cancer tissue has unique electrical properties that are different from non-cancerous tissue. The BioZ device uses a low-intensity electrical current that is applied from inside of the BioZ device that has small electrodes at the tip. To interrogate these electrical properties, the electrodes (tip of the device) will be placed on the skin in the area of the hip. Once this occurs, the electrodes will be activated and the low-intensity current will be applied. As the current moves through the skin the device has a probe to detect changes in current that may be associated with cancer. Data from the probe is related to a secure phone that has an app to collect information. It will take about 1 minute to complete the measurement. The measurement will be completed 3 times. The presence of AML or MDS triggers a complex cascade of physiological changes within the tissue matrix, including alterations in interstitial fluids, lymphatic activity, as well as cellular and anatomical structures. By quantifying the skin electrical contrasts associated with these pathological changes, a non-invasive skin BioZ measurement at the level of the posterior iliac crest could have significant clinical value as a simple way to follow up AML or MDS patients throughout their treatment course. Here, the development of BioZ technology could provide an accurate biomarker of disease progression and treatment in AML and MDS and enable clinicians to detect and provide life-saving treatment for AML and MDS patients.

Inclusion Criteria:

• Suspected or confirmed diagnosis of Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) and undergoing a bone marrow biopsy.
• Age 18 or older.
• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

• Study prospect that has an electronic implant (cardiac, neurological, sensory, prosthetic implants with an electronic component. Also monitoring and drug delivery systems.)
• Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
• Pregnant women
• Inability to understand and/or speak the English or Spanish language.