HER2

Breast cancer is a leading cause of death among women worldwide and is classified into subtypes based on hormone receptor and HER2 status. This research focuses on the role of epigenetic regulators, specifically non-coding RNAs like lncRNAs UPK1A-AS1 and UNC5B-AS1, which may influence gene expression involved in breast cancer development. Studying these molecular markers aims to improve diagnosis and prognosis and enhance understanding of breast cancer biology. The study is observational and involves Egyptian female breast cancer patients newly diagnosed with malignant non-metastatic breast cancer, compared to healthy volunteers. Researchers will measure the expression levels of the candidate lncRNAs and their target microRNAs using quantitative real-time PCR in serum and tissue samples. Protein levels related to these markers will be assessed by ELISA. The study will also analyze the relationship between these markers and clinical features such as tumor stage, grade, and known prognostic biomarkers. Participants will provide blood and tissue samples for molecular analysis, and clinical data will be collected from medical records. Laboratory tests include RNA extraction, qRT-PCR, and ELISA assays. The primary outcomes include evaluating the expression and role of the lncRNAs and their targets, comparing them between patients and healthy controls, and correlating these findings with clinical characteristics. The study will last about 12 months, with careful data analysis to explore potential new markers for breast cancer diagnosis and prognosis.

Researchers are evaluating the diagnostic performance of two PET tracers, 18F-FDG and 68Ga-FAPI-46, in female patients with estrogen receptor-positive ER breast cancer. This pilot study focuses on patients with locally advanced, recurrent, or metastatic breast cancer and aims to determine if 68Ga-FAPI-46 detects more lesions than 18F-FDG, potentially leading to more accurate staging and treatment decisions. The study is sponsored by Maastricht University Medical Center and is conducted as a Phase 2 interventional trial. All participants will undergo an additional 68Ga-FAPI-46 PETCT and PETMRI scan before starting breast cancer treatment. These imaging exams will be performed within 20 working days from diagnosis and alongside the standard 18F-FDG PETCT or PETMRI scans. The study focuses on comparing these two diagnostic tracers accuracy in detecting cancer lesions in ER breast cancer patients. Participants will be followed from diagnosis until both PET exams are completed. The researchers will collect data to help calculate sample size for future studies and explore the feasibility of taking biopsies from lesions identified by the new tracer. Safety and ability to complete imaging procedures will be monitored. The total participation duration covers the time needed to conduct both imaging exams and any related assessments.

Researchers are evaluating the diagnostic value of a new protein-specific probe called 18F-T2 in PETCT imaging for people with solid tumors that are likely to express high levels of CAIX protein. The study will also assess how safe and tolerable the 18F-T2 injection is, as well as measure its radiation dosage. This research is important to better understand how well 18F-T2 can detect these tumors compared to standard imaging techniques. Participants with tumors suspected to express high levels of CAIX will receive an intravenous injection of 18F-T2. About an hour after the injection, PETCT imaging will be performed to capture detailed images of the tumors. Within one week, participants will also undergo a whole-body PETCT scan using 18F-FDG, a commonly used imaging agent, to allow comparison between the two imaging methods. During the study, participants will be monitored for any adverse events within 24 hours after the 18F-T2 injection to evaluate safety and tolerability. Researchers will measure the diagnostic sensitivity and specificity of 18F-T2 PETCT for detecting CAIX-positive tumors. They will also assess uptake values in tumors on both 18F-T2 and 18F-FDG scans, analyze the correlation between 18F-T2 uptake and CAIX expression in tissue samples, and evaluate radiation dosimetry. The study will continue until one month after completion for outcome assessments.

Researchers are evaluating the cosmetic outcomes and quality of life for breast cancer patients undergoing breast reconstruction using 3D-printed biodegradable material breast implants. This study compares these results with traditional breast-conserving surgery and traditional silicone prosthesis breast reconstruction. It also explores the safety and potential medical issues related to using 3D-printed biodegradable implants for breast reconstruction in patients not suitable for breast-conserving surgery. Participants are divided into three groups one group receives breast reconstruction using 3D-printed biodegradable implants, the second undergoes traditional breast-conserving surgery, and the third has traditional silicone prosthesis breast reconstruction. The trial includes preoperative assessments, imaging with MRI, surgical planning with 3D printing of implants for the experimental group, and surgery according to each groups procedures. Postoperative care includes wound management, systemic therapies such as chemotherapy or endocrine therapy, and radiotherapy based on clinical guidelines. During the study, participants undergo regular follow-up with breast ultrasounds weekly for the first month and monthly thereafter, MRI scans at 3, 6, 12, and 24 months, and patient-reported outcome assessments using the BREAST-Q V2.0 scale to evaluate breast aesthetics, satisfaction, and quality of life. Telephone follow-ups occur monthly, with in-person visits every three months. The primary outcome measured is cosmetic effects and quality of life one year after surgery, alongside safety and long-term survival outcomes up to ten years.

This research aims to compare two radiotherapy approaches for women with breast cancer who are either under 40 years old or have unfavorable tumor types such as lobular carcinoma, certain aggressive subtypes, or triple negative breast cancer. The study focuses on patients with clinical stage T1-T3 and lymph node involvement Nx-N3 after breast-conserving surgery, evaluating whether a shorter, more intense treatment schedule is not worse than the current standard treatment. The trial is prospective, randomized, and designed to assess non-inferiority between these treatments. Participants will receive one of two radiation therapy regimens. One group experimental arm will have whole breast irradiation totaling 26 Gy delivered in 5 fractions, with a simultaneous integrated boost SIB to the tumor bed totaling 30 Gy. The other group standard arm will receive whole breast irradiation totaling 40.05 Gy in 15 fractions, with SIB to 48 Gy. Intensity modulated radiotherapy IMRT plans will be used to optimize coverage and protect organs at risk. Both treatments are given after surgery and may include lymph node areas. During the study, participants will be monitored for local relapse-free survival over 5 years, along with various toxicity assessments at 1 month, 3 months, and up to 5 years. Other outcomes include local control, breast tumor recurrence, regional relapse-free survival, distant metastasis-free survival, disease-free survival, breast cancer-specific survival, overall survival, and cosmetic results. Additional evaluations will assess treatment-emergent adverse events, organ movement, radiomics, and predictive factors for toxicity and disease progression. The study will run through June 2035.

Researchers are evaluating the difference between a 5-day course and a 9-day course of whole breast radiation therapy for women with early-stage breast cancer. This phase II randomized trial aims to compare patient satisfaction and side effects from these two radiation schedules to determine if the shorter treatment is as acceptable as the longer one. The study is sponsored by the University of Utah and focuses on women with specific breast cancer types and stages after lumpectomy surgery. Participants will be randomly assigned to receive either 5 fractions or 9 fractions of hypofractionated radiation therapy to the whole breast, with a boost to the tumor area. The radiation treatments are given over the respective number of days, and the study compares these two schedules to assess differences in outcomes. Both groups receive radiation therapy as directed by the study protocol, with no placebo or masking involved. During the study, participants will be followed for several years to evaluate breast satisfaction using Breast-Q scores and to monitor for radiation-related side effects and cancer recurrence. Various assessments will include cosmetic evaluations using photographic scales and patient-reported outcomes collected at multiple time points up to 5 to 8 years. Safety and effectiveness are monitored through adverse event tracking and cancer surveillance, with total study duration extending up to 8 years after treatment.

Researchers are studying whether 68Ga-FAPI PETCT scans can be a new effective way to evaluate axillary lymph nodes after neoadjuvant treatment in women with breast cancer. This observational study focuses on patients who have clinically positive axillary lymph nodes and have undergone treatment before surgery. The goal is to understand if this imaging method can better detect remaining cancer in lymph nodes compared to traditional methods. Participants will have a 68Ga-FAPI PETCT scan after completing at least three courses of neoadjuvant therapy and before surgery. This scan is being evaluated for its ability to detect residual disease in the lymph nodes without being affected by blood glucose levels, offering potentially clearer imaging. The study will observe participants without altering their treatment, focusing on this imaging test. During the study, participants will undergo the PETCT scan, and researchers will track how well the scan predicts residual cancer in the lymph nodes after treatment. They will measure the sensitivity and specificity of the scan up to the time of surgery, and follow participants for up to three years to see how well the scan predicts invasive disease-free survival and overall survival. Participants usual care will continue throughout the study, which starts in August 2024 and ends in June 2026.

Researchers are evaluating a new dual-target imaging agent called 68Ga-RM26-RGD for PETCT scans in patients with breast, brain, and prostate cancers that express specific receptors GRPR and integrin v3. This study aims to improve tumor detection by comparing this agent with conventional 18F-FDG and single-target imaging agents, addressing limitations of current imaging methods in detecting tumors with low 18F-FDG uptake or variable receptor expression. Participants will undergo PETCT scans using intravenous injections of 68Ga-RM26-RGD and one of the comparator agents 18F-FDG, 68Ga-RM26, or 68Ga-RGD within a two-week period. The dosages for these agents are approximately 1.8-2.2 MBqkg. Each patient receives scans with both agents to compare imaging performance directly. During the study, researchers will assess diagnostic accuracy and dosimetry of 68Ga-RM26-RGD over about one year. Participants will have multiple PETCT scans and related evaluations to monitor uptake of the imaging agents in tumors. The study includes safety and diagnostic performance monitoring throughout the participation period.

Researchers are evaluating the safety, feasibility, and diagnostic accuracy of a new PET tracer called 68Ga-SorB targeting Sortilin, a receptor highly expressed in several solid tumors including melanoma, liver, lung, pancreatic, breast, and ovarian cancers. This exploratory diagnostic study compares 68Ga-SorB PETCT imaging to the standard 18F-FDG PETCT, aiming to improve tumor detection and characterization by using a more tumor-specific tracer with fewer false positives. Participants will receive a single intravenous dose of 68Ga-SorB followed by whole-body PETCT imaging about 60 minutes after injection. The study compares these imaging results with clinically indicated 18F-FDG PETCT scans done within a set timeframe. No therapeutic treatments are given as part of this study. Approximately 40 to 50 adults with confirmed or suspected tumors will be enrolled for imaging and follow-up. During the study, participants are monitored for adverse events from tracer administration until about 24 hours post-imaging. Tumor uptake is measured using quantitative PET parameters such as SUVmax and tumor-to-background ratio. Follow-up includes pathology review and clinical assessments up to 3 months after imaging to evaluate lesion detection, diagnostic sensitivity, specificity, and overall accuracy. This research will provide initial clinical evidence to support further development of Sortilin-targeted imaging and potential future therapeutic applications.

Researchers are evaluating a new imaging agent called 99mTc-MY6349 to detect the presence of Trop2, a protein highly expressed in many cancers including triple-negative breast cancer. This study aims to monitor Trop2 expression in tumors using SPECTCT scans, helping to understand tumor characteristics and guide treatment decisions for patients considering the anti-Trop2 antibody gosatuzumab. Trop2 expression is linked to tumor growth, spread, and patient outcomes. Participants in this study will receive an injection of 99mTc-MY6349 followed by a SPECTCT scan to observe how well the tracer binds to Trop2 in the tumors. This imaging will be compared to 18F-FDG PETCT scans to analyze tumor locations and spread. The study focuses on triple-negative breast cancer patients and looks at the variation of Trop2 expression within primary and metastatic tumors to help inform potential treatment with gosatuzumab. During the study, participants will undergo imaging scans and evaluations of Trop2 levels in their tumors. Researchers will perform semi-quantitative analysis of the imaging results over about one year. The study monitors the ability of the new imaging method to predict response to targeted treatment and assesses tumor heterogeneity. Participants are expected to be followed until study completion with safety considerations for radiation exposure.