Early Cancer Detection with Circulating Tumor Cells
Cancer is discovered too late with imaging technologies and metastases are often discovered years after surgical removal of a primary tumor. It is commonly accepted that early metastases are often present at the time of initial surgery, even for early-stage patients. Identification, characterization, and enumeration of CTCs enables the detection of a primary tumor or a distant metastasis. Thus, such information would identify patients who would benefit from chemo or other therapy before or following surgical removal of a primary tumor, even without direct confirmation of metastatic spread.
Current technologies are not sufficient to detect early primary tumors or metastases, which inhibits a physician’s ability to determine the optimal treatment course in many situations. Consequently, a large percentage of patients receiving therapy do not benefit from it while others who could have benefitted do not receive it.
The following diagram illustrates the importance of early primary and metastatic tumor cell detection as well as the difficulty associated with such early detection.
Image source: Yang M, Zhang X, Guo L, Liu X, Wu J, Zhu H. Research Progress for the Clinical Application of Circulating Tumor Cells in Prostate Cancer Diagnosis and Treatment. Biomed Res Int. 2021 Jan 8;2021:6230826. doi: 10.1155/2021/6230826. PMID: 33506020; PMCID: PMC7814947.
An in vivo Approach for an Early Detection of Cancer
In order to detect the primary tumor or metastases earlier and provide curative therapy options for patients, a substantial improvement in imaging or CTC detection technologies would be required. Such an improvement would lead to detection of cancer or the identification of metastases ~2 years earlier, and would require at least a 50-fold improvement in CTC detection capabilities, or the ability to screen up to 1 liter of blood – an ability that is not (and will never be) approachable via a blood sample based approach.
Depending on the targeted cells, the BMProbe™ can be used for the early detection, monitoring and profiling of cancer.
Our Clinical Studies in Oncology
Since our BMProbe™ passed the biocompatible tests necessary for a cancer clinical trial we have developed our clinical study program with the Mayo clinic and Saint John’s Cancer Institute (formerly John Wayne Cancer Institute).
Our cancer program will start with prostate cancer and will be expanded with advanced non-small-cell lung carcinoma patients while receiving systemic therapy.
We will isolate and recover CTCs immediately prior to surgery and afterwards in regular intervals as part of regular follow-up examinations and in line with current standard protocols as defined by ASCO. The captured CTCs will be enumerated to demonstrate that CTC counts post-surgery correlate with likelihood of tumor relapse. Additionally, a molecular analysis will be performed. A successful proof of this correlation will confirm the establishment of a CTC analysis as a viable prognostic indicator of disease relapse.
The current standard of care for post-surgery monitoring is imaging diagnostics (MRI, CT scan, PET) typically performed on a six-month basis post treatment. These approaches are not sufficiently sensitive in most cases to identify rapid disease progression. HaimaChek™ will demonstrate the ability to detect disease relapse much earlier using the BMProbe™.
Source: Yang M, Zhang X, Guo L, Liu X, Wu J, Zhu H. Research Progress for the Clinical Application of Circulating Tumor Cells in Prostate Cancer Diagnosis and Treatment. Biomed Res Int. 2021 Jan 8;2021:6230826. doi: 10.1155/2021/6230826. PMID: 33506020; PMCID: PMC7814947.
CTC isolation with the BMProbe
Through our in vivo approach we are able to detect CTCs at very low quantities in blood to detect metastasis early. The BMProbe™ can provide a complete profile of the tumor similar to a tumor-biopsy.