Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Anti-Infective Agents

All Drugs and Chemicals

Other Dietary Supplements

Carbamide Peroxide

Pyruvate

The Participants in the active comparator arm will be injected with study drug Hyperpolarized Pyruvate (13C) Injection at a dose of 0.43/ml/kg.

After the injection research, MRI will be done and images evaluated.

Participants will receive an MRI with a 1 cm diameter plastic ball that contains 13C-urea that acts as test object. It provides a signal that is used to ensure that the MRI system is functioning properly.

The new imaging method being tested in this study is called Metabolic MRI, which provides pictures of the metabolism occurring within cancer cells. It also involves injection of a contrast medicine, Hyperpolarized Pyruvate (13C) Injection, into the arm vein. The Participants in the active comparator arm will be injected with study drug Hyperpolarized Pyruvate (13C) Injection at a dose of 0.43/ml/kg.

Hyperpolarized Pyruvate (13C) Injection

Participants will receive an MRI with a 1 cm diameter plastic ball that contains 13C-urea that will act as a test object. The test object provides a signal that will be used to ensure that the MRI system is functioning properly for participants in Group 2 . The plastic ball does not come in contact with you and there are no known risks associated with it.

Coil Testing

Participants will be receiving NAC as part of their clinical treatment.

Charles Cunningham, PhD

Breast cancer is the second most common form of cancer in women and the most frequent cause of death. Despite breast screening programs, a substantial number of women are diagnosed with cancers greater than 2 cm in size or locally advanced disease, which is best treated with neoadjuvant chemotherapy (NAC) prior to surgery. Approximately 10% of women diagnosed with breast cancer annually will have locally advanced breast cancer, defined as stage III disease, where the cancer has either spread to regional lymph nodes and/or other tissue in the area of the breast, but not to distant sites. NAC offers the advantages of downstaging the disease, potentially reducing the extent of surgery. Presently, gadolinium enhanced MRI is the standard test used to monitor disease response to chemotherapy, and demonstrates changes in tumour size and extent between pre-NAC and post-NAC. Unfortunately, changes in tumour size may occur late in treatment regimen, thus producing false-negative results on early magnetic resonance imaging (MRI). Therefore, newer imaging techniques beyond anatomical imaging are needed to identify tumours that are unresponsive to chemotherapy and potentially change treatment plan early on to avoid significant morbidity associated with prolonged chemotherapy.

A novel MRI technique utilizing hyperpolarized pyruvate has the potential to detect pathophysiological response early in the treatment regimen and would therefore allow for earlier identification of nonresponders and subsequent early modification of treatment regimens, if necessary.

Objectives:

Primary Objective To assess feasibility of of acquiring time resolved, 3D 13C pyruvate MR images of breast cancer requiring neoadjuvant chemotherapy after administration of hyperpolarized 13C pyruvate.

Secondary Objectives

1. To determine the diagnostic accuracy of time resolved, 3D 13C pyruvate MR imaging after administration of hyperpolarized 13C pyruvate for differentiating breast cancer from normal breast parenchyma.
2. To spatially correlate lactate seen on hyperpolarized 13C MR to anatomic imaging with conventional MRI.
3. To assess if hyperpolarized 13C pyruvate MR can differentiate between tumour necrosis versus viable tumour
4. To acquire statistical information to help design, fund, and power future clinical studies with larger patient populations.

Overall Study Design This is a pilot prospective, single-institution study in participants who will receive NAC. Participants will be first informed of the study by personnelle within the patient's circle of care. If the patient expresses interest in participating in the study, the study's Clinical Research Coordinator will approach the patient to provide further information, answer any questions, provide study documentation, as well as to obtain informed consent if agreeable. Clinical procedures will be completed at Sunnybrook Health Sciences Centre (SHSC) under the supervision of medically trained personnelle.

- Population: A total of 13 participants will be recruited for this study. Prior to the first study research MRI scan, we will scan up to 3 volunteer participants with a known breast malignancy (Group 1). These participants will not have hyperpolarized 13C pyruvate administered. They will be scanned with a 13C phantom in order to test the functionality of the 13C coil.

Subsequently, up to 10 volunteer participants with breast cancer requiring NAC, between 18 and 80 years of age with pathology- and imaging-confirmed breast cancer requiring NAC will be studied (Group 2). Imaging confirmation involves highly suspicious masses on mammography and/or ultrasound. Pathology confirmation involves image-guided core biopsy of the suspicious mass.

* Design: Each participant will receive one research MRI scan on the 3T MRI scanner prior to NAC. This visit will occur separately from the patient's clinical dynamic contrast enhanced (DCE) MRI.
* Scan Timing: The research MRI exam will be scheduled before the initiation of NAC, and within 5 days prior to, or following, the clinical MRI scan.

A total of 13 participants will be recruited for this study. Prior to the first study research MRI scan, 3 volunteer participants will be scanned with a known breast malignancy (Group 1). These participants will not have hyperpolarized 13C pyruvate administered. They will be scanned with a 13C phantom in order to test the functionality of the 13C coil.

Subsequently, up to 10 volunteer participants with breast cancer requiring NAC, between 18 and 80 years of age with pathology- and imaging-confirmed breast cancer requiring NAC will be studied (Group 2). Imaging confirmation involves highly suspicious masses on mammography and/or ultrasound. Pathology confirmation involves image-guided core biopsy of the suspicious mass.

Study to Evaluate the Feasibility of 13-C Pyruvate Imaging in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

Feasibility of of acquiring time resolved, 3D 13C pyruvate MR images of breast cancer requiring neoadjuvant chemotherapy after administration of hyperpolarized 13C pyruvate.

Diagnostic accuracy of time resolved, 3D 13C pyruvate MR imaging after administration of hyperpolarized 13C pyruvate for differentiating breast cancer from normal breast parenchyma.

Correlate lactate seen on hyperpolarized 13C MR to anatomic imaging with conventional MRI.

Differentiate between tumour necrosis versus viable tumour with Hyperpolarized 13C pyruvate MRI

Sunnybrook Health Sciences Centre

Technetium Tc 99m Sestamibi

Radiopharmaceuticals

Participants undergo 3 MBI scans with injections of injection of Tc99m sestamibi before each scan. First scan is 7 days before scheduled chemotherapy treatment, after 2 cycles of chemotherapy, and after completion of chemotherapy treatment.

Participants undergo 3 MBI scans with injections of injection of Tc99m sestamibi before each scan. First scan is 7 days before scheduled neoadjuvant chemotherapy (NAC) treatment, after 2 cycles of chemotherapy, and after completion of chemotherapy treatment.

Molecular Breast Imaging (MBI)

8 mCi of 99mTc sestamibi by vein before each molecular breast imaging (MBI).

Tc99m sestamibi

Gaiane M. Rauch, MD, PHD

This clinical trial studies technetium Tc-99m sestamibi molecular breast imaging in predicting tumor response in patients with locoregional breast cancer that has spread from where it began in the breast to surrounding normal tissue who are receiving neoadjuvant chemotherapy. Comparing results of diagnostic procedures, such as technetium Tc-99m sestamibi molecular breast imaging, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

PRIMARY OBJECTIVE:

I. To evaluate the ability of technetium Tc-99m sestamibi (Tc 99m sestamibi) molecular breast imaging (MBI) to predict early response to neoadjuvant chemotherapy (NAC) and to assess residual disease at the completion of NAC in patients with locoregional invasive breast cancer.

SECONDARY OBJECTIVES:

I. To evaluate and qualitatively characterize Tc 99m sestamibi uptake by tumor on MBI at the baseline, after 2 cycles of NAC and at the completion of NAC.

II. To compare assessment of tumor response to NAC by MBI with digital mammography (DM), and breast ultrasound (US) exams.

III. To compare tumor size and distribution observed from MBI at the completion of NAC with extent of residual disease at surgery by pathological evaluation.

IV. To develop image acquisition and processing algorithm that quantifies the Tc 99m tumor uptake.

EXPLORATORY OBJECTIVE:

I. To determine effect of molecular subtype of cancer (Her2+, ER/PR/Her2- and ER+/Her2-) on diagnostic performance of MBI in predicting treatment response.

OUTLINE:

Patients undergo technetium Tc-99m sestamibi molecular breast imaging over 45 minutes at baseline (before start of NAC), after 2 courses of NAC (6-12 weeks, depending on the regimen), and the completion of NAC but before surgery. Patients also undergo breast ultrasound and mammographic imaging as standard of care at the same time points.

Tc99m Sestamibi Molecular Breast Imaging

Assessment of the Tumor Response to Neoadjuvant Chemotherapy in Women With Locoregional Invasive Breast Cancer Using Tc99m Sestamibi Molecular Breast Imaging: A Prospective Study

Evaluation of treatment response by molecular breast imaging (MBI) tumor to background ratio (T/B), defined as T/B = ROIt_max/ROIb_mean, calculated.

M.D. Anderson Cancer Center

Rare Diseases

Pseudomyxoma Peritonei

Adenocarcinoma

Adenocarcinoma, Mucinous

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Cystic, Mucinous, and Serous

Respiratory System Agents

Acetylcysteine

N-monoacetylcystine

Antiviral Agents

Expectorants

Antioxidants

Protective Agents

Antidotes

Patients with pseudomyxoma peritonei that are not candidates to surgical resection

0.5mg per mL of total tumor volume calculated, administered percutaneously

Bromelin

20mg per mL of total tumor volume calculated, administered percutaneously

N-Acetylcysteine

Lidia Rodríguez Ortiz, MD

Álvaro Arjona Sánchez, PhD

This trial pursues studying a compassionate treatment option for patients with inoperable pseudomyxoma peritonei through percutaneous administration of bromelain + N-acetylcysteine (NAC) in order to decrease tumoral volume. Secondary endpoints are the decrease of ascites, compressive symptoms and pain through the dilution of mucins, which would better intestinal blockage.

Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei

Intratumoral Bromelain + N-acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei. Phase I Single-arm Trial

Data will be shared after the study concludes and results are published

Tumoral mass change calculated through CT Scan or Magnetic Resonance categorized regarding the biggest diameter per abdominal region

Symptoms progression evaluated through QLQ-C30 questionnaire (life quality questionnaire)

Period of time free of tumor progression.

Diminution of tumoral DNA amount found in mucin and blood samples

Maimónides Biomedical Research Institute of Córdoba

A skin-sparing mastectomy performed with preservation of the nipple-areolar complex (NAC). Questionnaires taking about 20-30 minutes to complete.

A skin-sparing mastectomy performed with preservation of the nipple-areolar complex (NAC).

NAC Sparing Mastectomy

Questionnaires taking about 20-30 minutes to complete.

Questionnaire

Gildy V. Babiera, MD

The goal of this study is to study nipple-areolar complex (NAC) sparing mastectomy as an alternative procedure to the standard skin-sparing mastectomy for women who have breast cancer or are at high-risk for developing breast cancer. You have been asked to take part in this study because your treating surgeon feels you are a candidate for skin-sparing mastectomy and because you want breast reconstruction after surgery. Outcomes that will be measured include how much nipple sensation can be kept after surgery; how satisfied you are with how the breast looks after surgery; complication rates; and your quality-of-life.

Operative Procedure:

You will have a skin-sparing mastectomy performed with preservation of the NAC. During surgery, the tissue will be tested while you are still under general anesthesia.

The NAC may be removed completely during the surgery if malignant cells are found during the testing done during the surgery or if suspicious cells that are not clearly benign cells are found. This will be up to your doctor. The NAC may also be removed surgically if the primary tumor is found to be located less than an inch from the border of the NAC, or you are found to have breast cancer with multiple "center" sites. The nipple can also be removed by itself, with the areola spared (this is called "areolar-sparing mastectomy") if your doctor is worried about its blood supply. These decisions will be made by your pathologist and treating surgeon.

You will then undergo immediate reconstruction, with either your own tissue, prosthetic tissue, or a combination of the two. This is up to your plastic surgeon. You will have met with your plastic surgeon before surgery to discuss the best reconstructive method for you, and you will be given an informed consent to sign at that time with details about the method you decide to use.

The breast tissue under the NAC will be biopsied and tested after your surgery. After that tissue has been tested, a second surgery may be needed if cancer cells are found, the tumor is too close to the NAC, or it has more than 1 "center" site. You will have the whole NAC removed in a separate operation. The place where the NAC was removed will be repaired by a plastic surgeon, who will choose the best method to get an acceptable cosmetic result. This may involve one or more extra surgeries, and you will be given separate informed consent documents to sign for each surgery.

Follow-up and Questionnaires:

If you agree to take part in this study, 4 sensory tests will be conducted on both breasts using a variety of hand-held devices. These tests are painless and will be performed at regularly scheduled follow-up visits in clinic. They will measure nipple and areolar sensitivity, as well as nipple erectibility. The tests will involve the placement of fibers of various thicknesses and blunt metal probes on the skin of your nipple and areola. All tests will be performed once before the surgery and then at about 3 months, 6 months, and 1 year after surgery, at your follow-up clinic visits.

Your breasts will be photographed at your 6-month and 1-year follow-up visits after surgery. At these visits, you will look at those photographs to decide how satisfied you are with how the breasts look. Two (2) plastic surgeons not directly involved in your surgery will also study those photographs by themselves and fill out a similar questionnaire rating their impression of the results of your plastic surgery. These results will not be made available to you. You will also complete 2 quality-of-life questionnaires within 1 month of your surgery, and then at 3 months, 6 months, 1 year, 2 years, and 5 years after surgery (+/- 1 month). The questionnaires will ask questions about nipple sensation, cosmetic outcomes, complications, and your quality of life. The questionnaires will take about 30 minutes to complete.

Length of Study:

You will remain on study for up to 5 years.

This is an investigational study. Up to 37 patients will take part in this study. All will be enrolled at MD Anderson.

A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy

Symptoms and General Pathology

Triple Negative Breast Neoplasms

Neoplasm, Residual

Neoplastic Processes

Ruth Stone

Julee Hartwell

Pavani Chalasani

A prospective, multicenter, observational study to evaluate the correlation of Molecular Residual Disease (MRD) detection using circulating tumor DNA guided test to pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC). Results from this study aim to improve MRD detection and disease outcomes for future patients.

NeXT Personal CTA (Clinical Trial Assay) is a patient-specific, tumor-informed device which allows for detection of MRD from cfDNA. By using next generation sequencing technology, whole genome sequencing (WGS) is conducted from DNA derived from patient tumor and normal samples. A tumor informed personalized panel is then constructed that uses only a selection of DNA targets from the WGS by applying bioinformatic filters. The targeted personalized panel is then sequenced using NGS and DNA derived from cfDNA from plasma samples. The data from the cfDNA NGS are then further analyzed using bioinformatics filters to report the MRD status.

FFPE, DNA extracted from blood, ctDNA extracted from plasma

ctDNA Based MRD Testing for NAC Monitoring in TNBC

Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients With Early Stage TNBC-Phase I (B-STRONGER-I)

NeXT Personal CTA clinical accuracy may be evaluated as compared to other clinically available tests. Stratification based on NAC therapy regimen, genomic profiles and biomarker analysis.

Evaluate genomic profile for specific biomarkers during neoadjuvant chemotherapy (NAC)

Evaluate the correlation of MRD detection by NeXT Personal CTA to pathological Complete Response (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC). The pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.

Evaluate the trajectory of changes in MRD detected by NeXT Personal CTA during neoadjuvant chemotherapy (NAC) to pathological Complete Response (pCR) or non pCR in stage I-III triple negative breast cancer (TNBC).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Evaluate the Feasibility of 13-C Pyruvate Imaging in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy	NCT03121989	Breast Cancer	Hyperpolarized ... Coil Testing NAC	18 Years - 80 Years	Sunnybrook Health Sciences Centre
Tc99m Sestamibi Molecular Breast Imaging	NCT02324387	Breast Cancer	Molecular Breas... Tc99m sestamibi	18 Years -	M.D. Anderson Cancer Center
Study to Evaluate the Feasibility of 13-C Pyruvate Imaging in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy	NCT03121989	Breast Cancer	Hyperpolarized ... Coil Testing NAC	18 Years - 80 Years	Sunnybrook Health Sciences Centre
Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei	NCT04982146	Pseudomyxoma Pe...	Bromelin N-Acetylcystein...	18 Years -	Maimónides Biomedical Research Institute of Córdoba
A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy	NCT00539227	Breast Cancer	NAC Sparing Mas... Questionnaire	-	M.D. Anderson Cancer Center
Tc99m Sestamibi Molecular Breast Imaging	NCT02324387	Breast Cancer	Molecular Breas... Tc99m sestamibi	18 Years -	M.D. Anderson Cancer Center
ctDNA Based MRD Testing for NAC Monitoring in TNBC	NCT06230185	TNBC - Triple-N... Minimal Residua...		18 Years -	Personalis Inc.

Spots Global Cancer Trial Database for nac

Every month we try and update this database with for nac cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nac

Every month we try and update this database with for nac cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nac cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.