Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Tamoxifen

Estrogens

Gretchen Benson, Ph.D.

Background:

- Studies have shown that changes in breast density (the amount of white area on a woman's mammogram) may be related to changes in breast cancer risk. Currently, there is no ideal way to measure breast density repeatedly over time. Researchers want to test whether ultrasound tomography scans can show changes in breast density. To examine these changes, healthy volunteers with no history of breast cancer and women who are taking tamoxifen will have ultrasound tomography scans.

Objectives:

- To test whether ultrasound tomography scans can show changes in breast density related to tamoxifen exposure.

Eligibility:

- Women between 30 and 70 years of age who are (a) taking tamoxifen or (b) healthy volunteers who have never had breast cancer.

Design:

* All participants will have a screening visit. Healthy volunteers will have one additional study visit; women taking tamoxifen will have three additional study visits.
* All participants will be screened with a physical exam and medical history. They will also give blood and saliva samples. This visit will also include an initial ultrasound tomography breast scan.
* For the healthy volunteers:
* At the study visit (12 months after the screening visit), participants will have a short interview and be weighed. They will also have an ultrasound tomography breast scan and provide a blood sample.
* For the women taking tamoxifen:
* At the second and third visits (1 to 3 months and 3 to 6 months after starting tamoxifen), participants will have a short interview. They will also be weighed and have an ultrasound tomography breast scan.
* At the fourth visit (12 months after starting tamoxifen), participants will have a short interview, weight measurement, and the ultrasound tomography breast scan, and will also provide a blood sample.
* All participants may be followed for up to 5 years after their final study visit.

Elevated breast density is one of the strongest risk factors for non-familial breast cancer \[1\]. Recently, the International Breast Cancer Intervention Study-1 (IBIS-1) trial reported that women whose mammographic density declined by 10% within 12-18 months of initiating tamoxifen chemoprevention also had a marked reduction in cancer risk \[2\]; however, preliminary data suggested that in 30% of patients, tamoxifen failed to lower density and did not reduce cancer risk. Therefore, we hypothesize that breast density represents a biosensor of tamoxifen response, reflecting bioavailability and action of active drug metabolites. Distinguishing tamoxifen responders from non-responders at the earliest time point would have value for making informed treatment decisions, providing a rationale for continued therapy among responders while sparing non-responders exposure to ineffective treatment. We propose to use a novel ultrasound tomography (UST) scanner to repeatedly assess volumetric breast density among 150 women during their first year of tamoxifen use for clinical indications, including a referral from a health professional based on a woman s personal risk of breast cancer or a diagnosis of atypical lobular or ductal hyperplasia (ALH/ADH), ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or invasive breast cancer, to assess whether tamoxifen-related declines in mammographic density found at 12 months can be identified earlier with UST. UST is ideally suited for this application because it produces volumetric data and avoids artifacts secondary to breast compression and exposure to potentially harmful ionizing radiation. For comparison, we will perform UST on a group of 150 age-, race-, and menopausal status-matched women without breast cancer in order to assess changes in UST density over time without tamoxifen exposure. The specific goal of this project is to utilize UST to describe the early time course of volumetric breast density change. The broader objective is to assess the concept of breast density as a biosensor of tamoxifen response and UST as a useful tool for making this determination.

The Ultrasound Study of Tamoxifen

National Cancer Institute (NCI)

Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.

Undergo ultrasound tomography using SoftVue

ultrasound tomography

magnetic resonance imaging

Alit Amit-Yousif, M.D.

This clinical trial studies ultrasound tomography using SoftVue in diagnosing women with breast cancer. New diagnostic procedures, such as ultrasound tomography using SoftVue, may help find and diagnose breast cancer.

PRIMARY OBJECTIVES:

I. Determine the in-vivo imaging potential of SoftVue through 3-dimensional (3-D) breast imaging.

II. Acquire data for SoftVue evaluation from a cohort of 100 women receiving standard ultrasound (US) evaluation as follow-up to mammographic or palpable abnormalities and construct reflection, sound speed and attenuation images with SoftVue.

III. Evaluate the ability of SoftVue to detect dominant breast findings (i.e. major normal landmark architecture) or masses previously identified with standard diagnostic evaluation (palpation, mammography, standard US) using standard clock position and radial distance measurements from the nipple.

IV. Conduct tomographic (i.e. slice-by-slice) comparison of SoftVue with magnetic resonance imaging (MRI) findings from a subgroup of 50 patients.

OUTLINE:

Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.

Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer

Clinical Data Collection for Initial Evaluation of SoftVue: a Novel Ultrasound Breast Scanner

For each type of resolution, observed values will be averaged over slices for each participant and compared to milestone values. The proportion of individuals whose images meet the milestone criteria will be reported with 95% confidence intervals calculated using Wilson's method.

The sensitivity of the SoftVue system to identify pathologic features will be estimated with 95% confidence intervals using previous imaging studies as the gold standard.

Will be calculated along with 95% confidence intervals.

Compare measured sound speed values against known values for the range of tissue types imaged (e.g. fatty breasts should have average sound speeds consistent with known speeds for fatty tissue).

Barbara Ann Karmanos Cancer Institute

Principal Investigator

Digestive System Diseases

Symptoms and General Pathology

Carcinoma

Liver Cirrhosis

Carcinoma, Hepatocellular

Fibrosis

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

Liver Extracts

Patients undergo B-mode ultrasound imaging of the liver over 15 minutes.

Ultrasound Tomography

Aya Kamaya

This pilot trial studies how well B-mode ultrasound imaging works in detecting liver cancer that is early in its growth and may not have spread to other parts of the body. Diagnostic procedures, such as B-mode ultrasound imaging, may help find and diagnose liver cancer and find out how far the disease has spread.

PRIMARY OBJECTIVES:

I. To investigate the use of quantitative ultrasound spectroscopy to detect early hepatocellular carcinoma (HCC) as an inexpensive and widely available quantitative (i.e. robust) method to confirm disease in developing countries.

OUTLINE:

Patients undergo B-mode ultrasound imaging of the liver over 15 minutes.

B-mode Ultrasound Imaging in Detecting Early Liver Cancer

Quantitative Ultrasound Spectroscopy to Early HCC

The Mid-band fit is related to the intensity of the returned ultrasound signal at different frequencies has been shown to change with tissue morphology.

Spectral intercept (SI) is mostly related to the number scatterers and their density in the tissue. Changes in the SI have been demonstrated to occur due to different pathologies and result from treatments that change the structure of the tissue being imaged.

Summarized as the maximum and/or average value over the lesion of interest (using a region of interest selection) and the liver image as a whole.

Stanford University

Professor of Radiology

Nervous System Diseases

Peripheral Nervous System Diseases

Breast Carcinoma In Situ

Carcinoma in Situ

Neuromuscular Diseases

Taxane

Patients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy.

Biopsy

Questionnaire Administration

Roy Strowd

This pilot clinical trial studies how well ultrasound works in detecting taxane-induced neuropathy in patients with breast cancer. Ultrasound may work better in diagnosing and detecting neuropathy in breast cancer patients treated with the chemotherapy drug called a taxane.

PRIMARY OBJECTIVES:

I. To compare tibial motor nerve ultrasound cross-sectional area (CSA) between taxane-induced peripheral neuropathy (TIPN) patients and historical data among healthy adults.

SECONDARY OBJECTIVES:

I. To compare sural sensory nerve ultrasound CSA between TIPN patients and historical data among healthy adults.

II. To determine if the above changes in nerve CSA correlate with NCS changes in the same TIPN patients.

III. To determine if the above changes in nerve CSA correlate with changes on a self-reported neuropathy scale (Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 \[QLQ-CIPN20\]) in the same TIPN patients.

IV. To determine if the above changes in nerve CSA correlate with intraepidermal nerve fiber (IENF) density changes on skin biopsy in the same TIPN patients.

TERTIARY OBJECTIVES:

I. To assess activated mast cells in skin biopsies in TIPN patients in relation to severity of symptoms and above findings.

II. To assess serum inflammatory markers in TIPN patients in relation to severity of symptoms and above findings.

OUTLINE:

Patients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy.

After completion of study, patients are followed up for 30 days.

Ultrasound in Detecting Taxane-Induced Neuropathy in Patients With Breast Cancer

A Pilot Study Using Ultrasound for the Detection of Taxane-Induced Peripheral Neuropathy

Spearman's rank correlation coefficient will be used to assess the associations between activated mast cells in skin biopsies, serum inflammatory markers, severity of symptoms, and primary outcome and secondary outcomes in taxane-induced peripheral neuropathy patients.

Will be determined by ultrasound in the tibial nerve. Will be compared to the historical data from healthy patients using two-sample t-test (two-sample t-test selected as primary data from the historical control patients is available and will be used for analysis). Will also compare the nerve cross-sectional area in our study sample to that in the historical diabetic neuropathy patients and historical oxaliplatin neuropathy patients using one-sample t-test. The general linear model will be used to evaluate any factors (e.g., age) that may be associated with the nerve cross-sectional area. Due

Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (amplitude of nerve response - ankle).

Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (conduction velocity of nerve response - tibial).

Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (distal latency of nerve response - ankle).

Spearman's rank correlation coefficient will be used to examine the association between nerve cross-sectional area and distal intraepidermal nerve fiber density.

Will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20. Spearman's rank correlation coefficient will be used to examine the associations between the cross-sectional area and the self-reported neuropathy scale.

Will be determined by ultrasound of the sural nerve. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies. The general linear model will be also used to evaluate the association after adjusting for one or two risk factors (e.g., age). Nerve cross-sectional area will be treated as the dependent variable.

Wake Forest University Health Sciences

Adverse Events were collected during the first treatment cycle. Historical control participants were not a part of this trial and were used as a reference group only. No adverse events were collected from this group.

Case

These patients were not enrolled as part of this study. This data comes from another study. Each of these n=60 patients had tests done on both left and right arms, which creates the n=120 samples found in the results.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Ultrasound Study of Tamoxifen	NCT01582074	Breast Neoplasm...		30 Years - 70 Years	National Institutes of Health Clinical Center (CC)
Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer	NCT01698658	Breast Cancer	ultrasound tomo... magnetic resona...	18 Years - 89 Years	Barbara Ann Karmanos Cancer Institute
B-mode Ultrasound Imaging in Detecting Early Liver Cancer	NCT02774161	Cirrhosis Early Hepatocel... Fibrosis Stage I Hepatoc... Stage II Hepato...	Ultrasound Tomo...	18 Years -	Stanford University
Ultrasound in Detecting Taxane-Induced Neuropathy in Patients With Breast Cancer	NCT03139435	Peripheral Neur... Stage 0 Breast ... Stage I Breast ... Stage IA Breast... Stage IB Breast... Stage II Breast... Stage IIA Breas... Stage IIB Breas... Stage III Breas... Stage IIIA Brea... Stage IIIB Brea... Stage IIIC Brea... Stage IV Breast...	Biopsy Questionnaire A... Ultrasound Tomo...	-	Wake Forest University Health Sciences
The Ultrasound Study of Tamoxifen	NCT01582074	Breast Neoplasm...		30 Years - 70 Years	National Institutes of Health Clinical Center (CC)
B-mode Ultrasound Imaging in Detecting Early Liver Cancer	NCT02774161	Cirrhosis Early Hepatocel... Fibrosis Stage I Hepatoc... Stage II Hepato...	Ultrasound Tomo...	18 Years -	Stanford University
Ultrasound in Detecting Taxane-Induced Neuropathy in Patients With Breast Cancer	NCT03139435	Peripheral Neur... Stage 0 Breast ... Stage I Breast ... Stage IA Breast... Stage IB Breast... Stage II Breast... Stage IIA Breas... Stage IIB Breas... Stage III Breas... Stage IIIA Brea... Stage IIIB Brea... Stage IIIC Brea... Stage IV Breast...	Biopsy Questionnaire A... Ultrasound Tomo...	-	Wake Forest University Health Sciences
Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer	NCT01698658	Breast Cancer	ultrasound tomo... magnetic resona...	18 Years - 89 Years	Barbara Ann Karmanos Cancer Institute

Spots Global Cancer Trial Database for ultrasound tomography