Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants undergo DWI over 15 minutes and MR spectroscopic imaging over 45 minutes.

Diffusion Weighted Imaging

Magnetic Resonance Spectroscopic Imaging

Michael A Thomas

This trial studies how well an imaging technique called magnetic resonance (MR) spectroscopic imaging works in identifying breast cancer in women with benign or suspicious areas in the breast. Magnetic resonance imaging (MRI) is a diagnostic tool used to investigate the location of tumors in different organs. Since radiological pictures do not have sufficient information for tumor grades, invasive procedure such as biopsy is performed on patients with breast cancers for diagnosis. Breast tissue contains water, fat, and chemicals known as metabolites. MR spectroscopic imaging may help to characterize the various breast metabolite steady state levels and identify the differences between necrosis and tumor recurrence, which is difficult using radiological procedures such as MRI.

PRIMARY OBJECTIVES:

I. Non-uniform undersampling schemes (NUS) will be combined with 5-dimensional (5D) echo-planar imaging based correlated spectroscopic imaging (EP-COSI) sequence.

II. Group sparsity (GS)-based compressed-sensing (CS) reconstruction schemes will be developed for accelerated acquisition and optimized to reconstruct the NUS EP-COSI data with better reliability.

III. Alterations in metabolite and lipid levels will be correlated with apparent diffusion coefficient (ADC) changes in breast cancer patients compared to healthy women which will improve the diagnostic accuracy.

OUTLINE:

Participants undergo diffusion weighted imaging (DWI)-MRI over 15 minutes and MR spectroscopic imaging over 45 minutes.

After completion of study, participants are followed up for 6 months.

MR Correlated Spectroscopic Imaging for Diagnosing Breast Cancer

Non-Uniformly Sampled MR Correlated Spectroscopic Imaging in Breast Cancer and Nonlinear Reconstruction

ADC maps will be calculated from diffusion weighted (DW) images by using linear regression of logarithmic intensities by using software for combinations of two, three, four, and five DW images with different b values. ADC maps will also be calculated for the remaining combinations of up to 10 evenly distributed b values. In total, 501 value combinations will be automatically processed and analyzed.

U.S. Army Medical Research and Development Command

U.S. Army Medical Research Acquisition Activity

Jonsson Comprehensive Cancer Center

So-Youn Jung

Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer localization.

In this study, our hypothesis are as following:

1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.

Indocyanine green, ICG (ICG-fluorescence)

* ICG is the most commonly used fluorophore which approve by FDA.
* NIR-F imaging with ICG could be used in various surgeries. For example, SLN mapping in breast cancer and localization of liver metastasis, especially superficial lesion
* Contains sodium iodide, patients who have history of allergy to iodides should be used as caution.

Nonpalpable benign brest lesion localization

* New method for the localization and resection of non-palpable breast lesions.
* The breast lesion was correctly localized, and the area of ICG corresponded well to the site of the lesions.

Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm.

Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm ; Observational Pilot Study for 20 Patients.

number of patients with pigmented skin lesion, number of patients with complication, number of patients with breast lymphedema, number of patients with residual breast lesion using breast ultrsound

non-palpable lesion localization rate = number of patients complete excision of lesion / 20 enrolled patients

actual lesion of width\*height\*length / resection lesion of width\*height\*length

National Cancer Center, Korea

Medical Dotor

Fibrocystic Breast Disease

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

All Drugs and Chemicals

Aspirin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Patients undergo standard of care breast biopsy for assessment of abnormalities seen on imaging, as well as collection of blood during screening. If cancer is found, patient is taken off study and treatment options are discussed with treating physician.

Patients without a cancer finding on biopsy then receive low-dose aspirin by mouth daily for 42-65 days and undergo collection of blood on study. Patients may undergo ultrasound guided breast biopsy as clinically indicated.

Biospecimen Collection

Low-Dose Aspirin

Questionnaire Administration

Ultrasound-Guided Biopsy

Clinical Trials Referral Office

Barbara A. Pockaj, M.D.

Sarah McLaughlin, M.D.

Kathryn J. Ruddy, M.D.

This phase II trial tests whether low-dose aspirin can affect markers of inflammation in postpartum (after childbirth) patients with benign breast disease planning to have a breast biopsy. Chronic inflammation may increase the risk of postpartum related breast cancer. Low-dose aspirin is a non-steroidal anti-inflammatory drug. Giving low-dose aspirin may affect markers of inflammation in blood and tissue and may prevent postpartum related breast cancer.

PRIMARY OBJECTIVE:

I. Pre- versus (vs) post-intervention change in postpartum-related breast cancer (PRBC) score.

SECONDARY OBJECTIVE:

I. Pre- vs. post-intervention change in postpartum involution (PPI) signature score.

EXPLORATORY OBJECTIVES:

I. Pre- vs. post-intervention change in percent of epithelial cells positive for COX-2, estrogen receptor (ER)/Ki67, gammaH2AX, and p16 in "normal" and in benign breast disease (BBD) lobule.

II. Pre- vs. post-intervention change in serum C-reactive protein (CRP), estrogens, insulin/insulin-like growth factors (IGFs), and adipokines.

III. Pre- vs. post-intervention changes in tissue and urine prostaglandins (PGs) and PGE2.

OUTLINE:

Patients undergo standard of care breast biopsy for assessment of abnormalities seen on imaging, as well as collection of blood during screening. If cancer is found, patient is taken off study and treatment options are discussed with treating physician.

Patients without a cancer finding on biopsy then receive low-dose aspirin orally (PO) daily and undergo collection of blood on study. Patients may undergo ultrasound guided breast biopsy as clinically indicated.

Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

Targeted Prevention of Postpartum-Related Breast Cancer

Will be calculated based on pre- and post-intervention for each person. Within person differences will be analyzed. The correlation between the change in PRBC score and change in PPI signature will be assessed using a Pearson correlation if both the scores are normally distributed. If either score is non-normally distributed, a Spearman correlation will be used instead. The correlation coefficient point estimate and 95% confidence interval will be reported.

Will be measured pre- and post-intervention for each person. Within person differences will be analyzed. The correlation between the change in PRBC score and change in the respective serum measures will be assessed using a Pearson correlation if both the values are normally distributed. If either value is non-normally distributed, a Spearman correlation will be used instead. The correlation coefficient point estimate and 95% confidence interval will be reported.

Will be measured pre- and post-intervention for each person. Within person differences will be analyzed. The correlation between the change in PRBC score and change in the respective PGs will be assessed using a Pearson correlation if both the values are normally distributed. If either value is non-normally distributed, a Spearman correlation will be used instead. The correlation coefficient point estimate and 95% confidence interval will be reported.

Will transform the biomarkers using Van der Waerden rank transformations. Will analyze data as within person differences for pre- versus post-treatment PRBC scores in tissues. The final mean difference in PRBC score point estimate and corresponding 95% confidence interval will be reported.

Will be calculated pre- and post-intervention for each person. Within person differences will be analyzed. The correlation between the change in PRBC score and change in PPI signature will be assessed using a Pearson correlation if both the scores are normally distributed. If either score is non-normally distributed, a Spearman correlation will be used instead. The correlation coefficient point estimate and 95% confidence interval will be reported.

National Cancer Institute (NCI)

Mayo Clinic

Rare Diseases

Triple Negative Breast Neoplasms

Carcinoma in Situ

Carcinoma, Lobular

Breast Carcinoma In Situ

Precancerous Conditions

Carcinoma, Intraductal, Noninfiltrating

Carcinoma, Ductal, Breast

Paget's Disease, Mammary

Carcinoma, Ductal

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Paget Disease of the Breast

Other Dietary Supplements

Omega 3 Fatty Acid

Docosahexaenoic Acid orally twice a day (PO BID) for 12 weeks.

Placebo orally twice a day (PO BID) for 12 weeks.

Docosahexaenoic Acid

Placebo

Ayca Gucalp

Powel H. Brown, MD

This randomized phase II trial studies how well docosahexaenoic acid works in preventing recurrence in breast cancer survivors. Docosahexaenoic acid supplement may prevent recurrence in breast cancer survivors.

PRIMARY OBJECTIVES:

I. To determine whether treatment with docosahexaenoic acid (DHA) for 12 weeks at 1000 mg twice daily as compared to placebo reduces normal breast tissue levels of tumor necrosis factor-alpha (TNF-alpha) in overweight and obese patients with a history of stage I-III invasive breast cancer, ductal carcinoma in situ (DCIS), Paget's disease, lobular carcinoma in situ (LCIS), or proliferative benign breast disease.

SECONDARY OBJECTIVES:

I. To investigate the effect of DHA at 1000 mg twice daily on tissue biomarkers

* Change from the baseline in cyclooxygenase-2 (COX-2)/interleukin-1-beta (IL-1beta)/aromatase measured by quantitative real-time polymerase chain reaction (PCR).
* Change from the baseline in crown-like structures of the breast (CLS-B) measured by immunohistochemical techniques for cluster of differentiation (CD)68.
* Change from baseline in CLS-B index determined as follows: (\[number of slides with evidence of at least one CLS-B\]/\[total number of slides examined\]).
* Change from baseline in CLS-B/cm\^2 defined as the number of CLS-B/cm\^2. II. Evaluate age as a predictor of CLS-B and inflammatory biomarkers (TNF-alpha/COX-2/IL-1beta) at baseline and over the time of treatment.

III. Evaluate red blood cell (RBC) fatty acid level as a surrogate of compliance.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive docosahexaenoic acid orally (PO) twice daily (BID) for 12 weeks.

ARM II: Patients receive placebo PO BID for 12 weeks.

Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors

A Multicenter Phase II Study of Docosahexaenoic Acid (DHA) in Patients With a History of Breast Cancer, Premalignant Lesions, or Benign Breast Disease

Differences in normal breast tissue levels of TNF-α 12 weeks post-treatment relative to pre-treatment for active treatment and placebo arm, compared using analysis of covariance where the post-treatment measurements were used as a dependent variable and the pretreatment measurements were included as a covariate in the analysis. For the primary study end-point TNF-α levels will be measured by quantitative real-time PCR (mRNA essays) on extracted RNA from breast core biopsies. Relative expression determined using the Computed Tomography (ΔΔCT) analysis protocol.

An indicator of whether a subject is detected with CLS-B or not.

To assess the severity of CLS-B using the following formula: number of CLS-B/cm\^2. The absolute change in the CLS-B/cm\^2 calculated according to the formula; Change in CLS-B/cm\^2 = (post-treatment CLS-B/cm\^2) - (pre-treatment CLS-B/cm\^2).

Biomarkers COX-2 are measured by quantitative real-time PCR. Differences between active treatment and placebo arm for each biomarker will be compared using analysis of covariance where the post treatment measurements will be used as a dependent variable and the pretreatment measurements will be included as a covariate in the analysis.

Biomarkers IL-1Beta are measured by quantitative real-time PCR. Differences between active treatment and placebo arm for each biomarker will be compared using analysis of covariance where the post treatment measurements will be used as a dependent variable and the pretreatment measurements will be included as a covariate in the analysis.

Biomarkers Aromatase are measured by quantitative real-time PCR. Differences between active treatment and placebo arm for each biomarker will be compared using analysis of covariance where the post treatment measurements will be used as a dependent variable and the pretreatment measurements will be included as a covariate in the analysis.

Whole blood samples collected for red blood cell fatty acid analyses at baseline and week 12 (+ 2 weeks). RBC fatty acid composition analyzed by gas chromatography (GC) with flame ionization detection.

Docosahexaenoic Acid 1000 mg orally twice a day for 12 weeks.

DHA 1000 mg orally twice a day for 12 weeks.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Powel H. Brown, MD/Chair, Clinical Cancer Prevention

Baseline

Post-Treatment

Post-treatment vs. Baseline Change

Docosahexaenoic Acid (DHA) 1000 mg orally twice a day for 12 weeks.

6 participants in the Placebo group and 1 participant in the DHA group were not evaluable due to tissue was not available quantitative RT-PCR.

Normal Breast Tissue Expression of Tumor Necrosis Factor Alpha (TNF-alpha) Levels

Post-treatment

Positive both Baseline and Post-treatment

4 participants on the placebo arm and 1 participant on the DHA arm did not have a post treatment biopsy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MR Correlated Spectroscopic Imaging for Diagnosing Breast Cancer	NCT06090630	Benign Breast N... Breast Carcinom... Malignant Breas...	Diffusion Weigh... Magnetic Resona...	18 Years - 80 Years	Jonsson Comprehensive Cancer Center
Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm.	NCT02172989	Benign Breast N...		20 Years - 70 Years	National Cancer Center, Korea
Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer	NCT05557877	Benign Breast N... Breast Carcinom... Breast Fibrocys...	Biospecimen Col... Low-Dose Aspiri... Questionnaire A... Ultrasound-Guid...	18 Years - 45 Years	Mayo Clinic
Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm.	NCT02172989	Benign Breast N...		20 Years - 70 Years	National Cancer Center, Korea
Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors	NCT01849250	Benign Breast N... Ductal Breast C... Invasive Breast... Lobular Breast ... Paget Disease o... Stage IA Breast... Stage IB Breast... Stage IIA Breas... Stage IIB Breas... Stage IIIA Brea... Stage IIIB Brea... Stage IIIC Brea...	Docosahexaenoic... Placebo	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for benign breast neoplasm