Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Skin Neoplasms

Carcinoma, Squamous Cell

Carcinoma, Basal Cell

Skin Diseases

Method for noninvasive detection of cutaneous malignancies

The device collects two types of tissue spectra: i) laser-induced fluorescence spectra and ii) white light reflectance spectra. This portable reflectance spectrofluorimeter collects spectra in a fraction of a second. Light collection and delivery are achieved via an optical fiber probe. The optical fiber probe is approximately 1 mm in diameter and 3 m long. The same probe collects light emitted from the tissue and delivers it back to the instrument for spectral analysis.

Spectral Diagnosis Probe

Michael Migden, MD

The goal of this clinical research study is to evaluate the use of an imaging technology called spectral diagnosis. Researchers want to find out if a special spectral-diagnosis probe can be used to detect skin cancers.

The spectral-diagnosis probe being used in this study uses dim pulses of light to identify features of tissue that may be related to the status of skin cancer. The probe is shaped like a catheter, and it has a camera on the end, which takes pictures of the skin.

If you agree to take part in this study, you will be asked questions about your age, race, smoking status, and the status of any diseases you may have (such as diabetes, connective tissue disease, and infectious disease). It should take about 5 minutes to answer these questions.

The study doctor will then decide which of your lesions are suitable for imaging by the probe. If necessary, any hair on or around the lesion(s) will be shaved or trimmed. The area(s) of skin being imaged will be cleaned with rubbing alcohol.

As part of your exam, the study doctor will use the probe to measure the selected areas of tissue. To perform the spectral-diagnosis measurement, the probe will be gently placed on the surface of your skin. Each selected area of your skin will take about a few seconds to image. The probe will shine different types of light onto the skin, and it will collect the light that reflects from the skin surface. The light signals will be stored so that researchers can look at them. Preparing the lesion, imaging it, and collecting the light signals should take about 10-15 minutes per lesion.

After all of the imaging is over, you will have biopsies performed on the lesions that your study doctor has decided are in need of such treatment as part of your standard care.

After this clinic visit, your participation in the study will be over.

This is an investigational study. The imaging probe is not commercially available or FDA approved. At this time, it is being used in research only. Up to 150 patients will take part in this study. All will be enrolled at M. D. Anderson.

Spectral Diagnosis of Cutaneous Malignancy

University of Texas at Austin

M.D. Anderson Cancer Center

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Michael Sughrue, MD

This is a pilot, observational study to evaluate the intraoperative sensitivity of the Chaos Wand in detecting tumor tissue with glioblastoma disease.

This is a pilot study to investigate if the Chaos Wand Spectral Diagnosis Probe can be used to identify Glioblastoma (GBM) cancer cells in patients undergoing standard surgical resection. Eligible patients who have consented to the use of the Chaos Wand will be scheduled for surgery as standard cancer care for GBM. During the surgical procedure, the Chaos Wand Spectral Diagnosis Probe will be utilized. Fifteen intraoperative readings and signal recordings of GBM tissue will be taken. The wand will only be used in areas that have already been deemed in need of resection due to GBM disease. Each site identified for spectral analysis will be marked. The wand does not come into contact with the brain at any point during this procedure. Following surgical resection of the GBM tumor, tissue will be collected from the same 15 sites where the Chaos Wand was used. The pathology report will be compared with the results of spectral analysis.

Spectral Analysis Probe to Identify Glioblastoma Cells

Pilot Study Utilizing a Spectral Analysis Probe to Identify Glioblastoma Cells in Patients With Glioblastoma Undergoing Standard Surgical Resection

For participants newly diagnosed with glioblastoma multiforme or patients who are suspected of having glioblastoma on pre-operative imaging who consent to the use of the Chaos Wand during surgery, 15-20 spectral readings will be compared to histopathology as ground truth to measure the sensitivity of the Chaos Wand to detect glioblastoma. For example, if a patient has 15 spectral readings but only 13 are histologically consistent with cancer, then the sensitivity of the wand would be 13/15\*100 = 87%. A mean value with standard deviation will be reported across all participants in the study.

For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of intracranial hemorrhage during the post-operative hospital course will be measured.

For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of ischemic stroke during the post-operative hospital course will be measured.

For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of surgical site infection during the post-operative hospital course will be measured.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Spectral Diagnosis of Cutaneous Malignancy	NCT00476905	Skin Cancer	Spectral Diagno...	18 Years -	M.D. Anderson Cancer Center
Spectral Analysis Probe to Identify Glioblastoma Cells	NCT03293888	Glioblastoma		18 Years -	University of Oklahoma

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