Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Symptoms and General Pathology

Prostatic Neoplasms

Erectile Dysfunction

Hypothermia

Urinary Incontinence

Enuresis

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Urination Disorders

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Lower Urinary Tract Symptoms

Urological Manifestations

Mental Disorders

Psychotic Disorders

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Body Temperature Changes

After Subjects arrive at the MRI facility, subjects will fill out a medical questionnaire that will be used to determine whether a MRI study can be performed. The investigators will determine whether there are any problems that make the subject not suitable for participating in this study.

Thomas E Ahlering, MD

Urinary incontinence and sexual dysfunction are potential side effects for men undergoing the successful removal of the cancerous prostate via surgery. Hypothermic cooling via the investigational Endorectal Cooling Balloon has been shown by our group to significantly reduce long term urinary incontinence and may reduce sexual dysfunction in men after robotic prostatectomy, and improve the patient's long term quality of life (QOL). However before successful translation of the endorectal balloon can proceed into the world wide usage, we must understand:

1. How effectively the tissues for continence and sexual function are cooled within the pelvis.
2. What is the capacity of vascularized structures (i.e. the neurovascular bundle) to 'cool sink' or diminish the effective cooling and
3. Determine if the endorectal balloon can be re-designed for improved QOL outcomes in men.

This research study marries two new techniques of Thermal MRI imaging and Endorectal cooling for prostate cancer surgery. MRI is non-invasive. A simple confirmation of effective hypothermic cooling can be achieved by novel MRI thermal mapping of the cooling gradient as it comprehensively sweeps through the rectum across the urogenital pelvis. MRI with temperature adaptive software can accurately map these gradients with non-invasive technique, and answer formidable questions of the effectiveness of hypothermic cooling of the prostate and its direct translation into improved continence and sexual function after surgery. The purpose of this research study is to use Magnetic Resonance Imaging (MRI) and Thermal MRI with subjects who will receive the investigational endorectal cooling balloon to help further understand how the cooling balloon works, which may translate to other uses in the future, including the diagnosis of patients at a high risk of developing prostate cancer.

Prostate cancer is the second most frequent cause of cancer death in men and it accounts for 11% of all male cancers. Radical prostatectomy remains the gold standard for localized disease, offering the advantage of precise staging and grading and the real possibility of disease eradication. In the US there are approximately 100,000 radical prostatectomies (RP) performed for prostate cancer annually. However, there are two major challenges to the quality of life outcomes after radical prostatectomy: preserving urinary continence, and sexual function. The quality of life (QOL) after radical prostatectomy relies on the return of continence and sexual function after surgery to their pre-operative 'normal' status. The main factor which determines potency rates for patients is whether or not the nerves at the Neurovascular Bundles (NVB), are spared, and it may take years for sexual function to return. This may be due to the nerve injury from the nerve trauma in the surgical procedure. Similarly, a major factor involved in post-radical prostatectomy incontinence is preservation of the nerves that control the external urethral sphincter, bladder, and urogenital diaphragm. Also Inflammation from surgical removal of the prostate not only affects nerves, but also may directly damage the bladder, urethra, and pelvic floor. Effective strategies to prevent this damage are currently lacking. One stratagem to prevent or minimize such damage, is the use of local hypothermia with ice or cold irrigation around the nerves and tissues prior to, during, and after the injury has occurred. In numerous experimental models of central and peripheral nervous system injury, the use of moderate hypothermia (i.e. 28-33oC) has been shown to provide dramatic neuroprotection safely in humans, during cardiac, kidney, and brain surgery for many years.

MRI Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal Balloon

MRI (Magnetic Resonance Imaging) Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal Balloon

During pre and post hypothermia, initial temperatures will be measured simultaneously on five 3-mm-thick image slices that covered the target. The thermometry scan can be repeated every 6 s. Tissue temperature map is measured by magnetic resonance thermometry (echo planar imaging with multiphase; field of view: 25 × 25 cm; matrix 256 × 256; number of excitations: 1; repetition time: 545 ms; echo time: 20 ms; flip angle: 20°; slice thickness: 3 mm); (b) a thermal map of the tissue volume will be superimposed on the anatomical image.

Before the subject's scheduled radical prostatectomy surgery, they will have an MRI combined with an cooling endorectal balloon (this study), which will 1. Show the dimensions of their lower pelvis, including the prostate, and 2.Measure how cold the tissue around the prostate becomes using the cooling balloon. The thermal MRI images will allow elucidation of temperatures at specified anatomic locations and their changes over time. Data will be described using means for normally distributed continuous variables. We will test for associations between temperature and continence using t-tests to compare temperature change between those who achieve continence at 30 and 60 days and those who do not.

University of California, Irvine

Vice Chairman and Urology Professor

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Patients reporting for oral cavity examination with the possibility or certainty of oral lesions

Oral cavity will be imaged by a thermal camera.

no intervention, observation only

Arie Orenstein, Prof.

Previous studies indicate that there are significant differences in the temperature of tumors and normal, adjacent tissues. The present study will test this hypothesis for lesions in the oral cavity. Thermal images of the oral cavities of patients, undergoing examination in the Department of Oral and Maxillofacial Surgery of Sheba hospital, will be compared to the diagnoses of the examining doctors. The results, apart from enhancing the delineation of oral cavity tumors, may help the decision to develop miniature thermal cameras to scan thermally, the GI tract.

Detecting Lesions in the Oral Cavity With Thermal Imaging

Sheba Medical Center

Prof. Arie Orenstein , Director Advanced Technologies Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Subjects who are scheduled for biopsy will be enrolled.

Patients who underwent screening mammogram will be enrolled.

Subjects scheduled for diagnostic mammogram will be enrolled.

Subjects with prior history of lumpectomy scheduled for their routine mammogram will be enrolled.

One-time Thermal imaging is performed for this cohort.

Thermalytix

Pavani Chalasani, MD

This trial is to study a new breast imaging tool called Thermalytix™. ThermalytixTM is a new radiation-free, automated breast cancer screening technique that uses Artificial Intelligence (AI) over thermal images. Thermal images are heat signatures in our body. This new technique will capture heat signatures in the breast and analyze those images with AI software. This study will evaluate the performance of ThermalytixTM breast imaging against standard imaging modalities, such as mammography and ultrasound.

Novel Thermal Imaging Technique for Breast Screening

A Phase II Study to Evaluate Accuracy of ThermalytixTM in Detecting Breast Cancer

Determine sensitivity and specificity of ThermalytixTM in detecting breast cancer in patients scheduled to undergo breast biopsy (Cohort 1). The sensitivity and specificity will be estimated using 95% exact binomial confidence intervals. The required sample size was determined based on the target sensitivity and specificity, and the resulting confidence intervals.

To determine accuracy of ThermalytixTM in assessing need for biopsy in patients who are found to have abnormal screening mammogram. Cohort 1 subjects will be used to determine this endpoint. The sensitivity and specificity will be estimated using 95% exact binomial confidence intervals. The required sample size was determined based on the target sensitivity and specificity, and the resulting confidence intervals.

To compare ThermalytixTM with screening mammogram in healthy subjects undergoing routine screening. Cohort 2 will be used to assess this endpoint. The specificity will be estimated using 95% exact binomial confidence intervals. The required sample size was determined based on the target specificity, and the resulting confidence intervals.

To compare ThermalytixTM with diagnostic mammogram in subjects who underwent diagnostic mammogram. Cohort 3 will be used for this endpoint. The specificity will be estimated using 95% exact binomial confidence intervals. The required sample size was determined based on the target specificity, and the resulting confidence intervals.

To compare ThermalytixTM with mammogram result (screening or diagnostic) in women who underwent lumpectomy. Cohort 4 will be used for this endpoint. The specificity will be estimated using 95% exact binomial confidence intervals. The required sample size was determined based on the target specificity, and the resulting confidence intervals.

Patient experience with ThermalytixTM will be documented via questionnaires. On a scale of 1-5, patients will document their experience during their mammogram and Thermalytix exam; in general, higher values indicate a better outcome.

University of Arizona

Uterine Cervical Neoplasms

3 groups of patients will be participated: women with cancer, women with premalignant lesions and women with a normal cervix. All patients will undergo the same examination

Examination of the cervix by thermal imaging camera

Thermal imaging

Yfat Kadan, Dr

When screening results for cervical premalignant lesions are positive, colposcopy is recommended. This is highly sensitive screening method. However, specificity of the test is of low.

Thus, a technology that improves the accuracy of the colposcopic exam is needed.

This is a feasibility study with the goal of examining the performance of a thermal imaging camera in the detection of cervical malignant and premalignant lesions.

Thermal Imaging for Evaluation of the Cervix

Thermal Imaging for Cervical Cancer Screening and Early Detection

Meir Medical Center

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Thermal imaging sessions, each taking approximately 10 minutes.

Thermal Imaging

Zhongxing Liao, MD

The goal of this clinical research study is to evaluate whether thermal imaging (recording body temperature) can be used to check the body's response to cancer therapy.

Primary Objective:

* The primary objective of this study is to establish techniques and methodologies of quantifying thermal signatures and their changes for cancer patients undergoing chemoradiation therapy.

Secondary Objective:

* The secondary objective is to evaluate correspondence between changes of thermal signature of a normal organ, e.g. lung or esophagus, versus the toxicity of that organ from chemoradiation therapy.

For Patients:

THERMAL IMAGER:

A thermal imager (a camera similar to a digital camera) takes pictures of skin surfaces. The imager is able to view temperature distribution of the skin surface.

STUDY PARTICIPATION:

If you agree to take part in this study, your body temperature will be measured with thermal imaging.

You will have thermal imaging sessions several times before the cancer treatment starts and during the therapy course. You will be given detailed instructions on how to prepare for the imaging sessions ahead of time as well as what to expect during the imaging sessions.

Before beginning thermal imaging, your temperature will be measured with a thermometer. To perform thermal imaging, you will be asked to take off all of your clothes in a private room and stand still in front of a thermal imaging camera. No one will be present while you disrobe. When you have finished taking off your clothes a radiation oncologist or other medical doctor will record several pictures from a computer stationed outside the room. Pictures of your front, back, and side views will be taken. These pictures will look like a silhouette (body outline) with thermal coloring. The entire imaging session should take about 10 minutes to complete each time.

LENGTH OF STUDY:

Your participation will be over in this study after the thermal images have been recorded.

This is an investigational study. Thermal imaging is FDA approved and commercially available for breast cancer screening. Its use in this study is investigational. Up to 35 patients will take part in this study. All will be enrolled at M. D. Anderson.

For Volunteers:

THERMAL IMAGER:

A thermal imager (a camera similar to a digital camera) takes pictures of skin surfaces. The imager is able to view temperature distribution of the skin surface.

STUDY PARTICIPATION:

If you agree to take part in this study, your body temperature will be measured with thermal imaging.

You will have thermal imaging sessions several times during the course of this study. You will be given detailed instructions on how to prepare for the imaging sessions ahead of time as well as what to expect during the imaging sessions.

Before beginning thermal imaging, your temperature will be measured with a thermometer. To perform thermal imaging, you will be asked to take off all of your clothes in a private room and stand still in front of a thermal imaging camera. No one will be present while you disrobe. When you have finished taking off your clothes a radiation oncologist or other medical doctor will record several pictures from a computer stationed outside the room. Pictures of your front, back, and side views will be taken. These pictures will look like a silhouette (body outline) with thermal coloring. The entire imaging session should take about 10 minutes to complete each time.

Volunteers will not participate in any part of cancer treatment, diagnostic imaging tests (CT, PET, etc), or any other clinical procedures in MD Anderson. Volunteers will not need to see physicians at MD Anderson or elsewhere. Thermal images will be taken 4 times during one day for a volunteer (morning, midmorning, earlier afternoon, late afternoon). Volunteers should not take any medications or perform any other medical procedures from morning to late afternoon until the thermal imaging is completed.

LENGTH OF STUDY:

Your participation will be over in this study after the thermal images have been recorded.

This is an investigational study. Thermal imaging is FDA approved and commercially available for breast cancer screening. Its use in this study is investigational. Up to 10 volunteers without cancer (5 males and 5 non-pregnant females) will take part in this study. All will be enrolled at M. D. Anderson.

Thermal Signature of Patients Undergoing Radiation Therapy

Phase I Assessment of Thermal Signature of Patients Undergoing Radiation Therapy

Body temperature at the time of the thermal imaging taken using a commercial infrared camera; thermal imaging sessions several times before the cancer treatment starts, during and after the radiotherapy courses. Using thermal images taken from multiple sessions, both the absolute and relative changes of the temperature distribution will be calculated and analyzed. The location of the regions will be guided by the diagnostic computed tomography (CT) and Positron Emission Positron emission tomography (PET)/CT images for temperatures at multiple angles of body, site of radiation for skin reaction, primary cancer site and critical normal organs.

Chemoradiation related toxicity, including hematological and nonhematological acute and late side effects assessed during each clinic visit and follow up session including patient clinical symptoms and clinical assessment of treatment-related toxicity as assessed by NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MRI Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal Balloon	NCT01979848	Prostate Cancer Hypothermia Urinary Inconti... Erectile Dysfun...		21 Years -	University of California, Irvine
Detecting Lesions in the Oral Cavity With Thermal Imaging	NCT00868725	Carcinoma, Squa...	no intervention...	-	Sheba Medical Center
Detecting Lesions in the Oral Cavity With Thermal Imaging	NCT00868725	Carcinoma, Squa...	no intervention...	-	Sheba Medical Center
Novel Thermal Imaging Technique for Breast Screening	NCT05650086	Breast Cancer	Thermalytix	21 Years -	University of Arizona
Novel Thermal Imaging Technique for Breast Screening	NCT05650086	Breast Cancer	Thermalytix	21 Years -	University of Arizona
Thermal Imaging for Evaluation of the Cervix	NCT02908607	Cervical Neopla...	Thermal imaging	18 Years -	Meir Medical Center
Thermal Signature of Patients Undergoing Radiation Therapy	NCT00508313	Lung Cancer	Thermal Imaging	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for thermal imaging