Breast Cancer

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.

This research aims to understand how patients with cancer respond to COVID-19 vaccination by studying the levels of protective antibodies over time. The focus is on individuals with solid organ malignancies receiving various anti-cancer treatments such as chemotherapy, targeted therapy, and immunotherapy, as well as those who have been disease-free for at least six months. Since cancer patients were excluded from initial vaccine trials, this study seeks to fill knowledge gaps about vaccine safety and effectiveness in this group. Participants include cancer patients who are either undergoing active treatment or are disease-free for six months or more. They are grouped based on their treatment type chemotherapy, targeted therapy, immunotherapy, or disease-free status. The study involves monitoring antibody trends related to COVID-19 infection and vaccination at multiple time points over a 12-month period. During the study, researchers will collect blood samples to measure neutralizing and spike antibody levels every three months for up to one year. Participants will be followed to track their immune response depending on their cancer treatment and biological aging status. The study will also assess how antibody levels change over time and correlate with different treatments and patient characteristics. Safety and consent are carefully monitored throughout the trial.

Researchers are evaluating 177Lu-RAD204, a radiolabeled antibody targeting PD-L1, in a Phase 01 study involving participants with advanced solid tumors that express PD-L1. The study aims to assess the safety, tolerability, biodistribution, radiation dosimetry, and preliminary anti-tumor effects of this treatment. The main goal is to find the maximum tolerated dose and recommended doses for future studies in participants with cancers such as NSCLC, SCLC, triple-negative breast cancer, melanoma, head and neck cancer, endometrial cancer, and others with specific genetic markers. The study includes a pre-screening period for PD-L1 testing if needed, followed by a screening period lasting up to four weeks. Participants undergo a Phase 0 Imaging Period where a low dose of 177Lu-RAD204 is given to assess imaging quality, safety, and dosimetry over two weeks. This may be followed by a Phase 1 Treatment Period with escalating doses of 177Lu-RAD204 administered in cycles lasting six weeks each. Participants may receive multiple treatment cycles based on clinical benefit and safety evaluations. Dose-limiting toxicity is monitored for six weeks after the first treatment dose, and dosing intervals may be adjusted as agreed by the study team. During the study, participants will have imaging scans, safety evaluations, and laboratory tests to track the distribution and effects of 177Lu-RAD204. Researchers will measure pharmacokinetics, radiation dosimetry, and tumor responses up to 30 weeks. Safety and tolerability are closely monitored throughout. Participants must meet specific health and tumor criteria to join and will be observed for any adverse reactions. The total duration of participation varies depending on treatment response and tolerability.

Researchers are evaluating 177Lu-BetaBart, a 177Lu-labeled anti-B7-H3 monoclonal antibody, in patients with various relapsed or refractory solid tumors that are locally advanced, inoperable, or metastatic. This Phase 12a study aims to understand the safety, tolerability, how the drug moves through and affects the body, and early signs of anti-tumor activity. Eligible participants include adults 18 and older with cancers such as castration-resistant prostate cancer, colorectal cancer, lung cancers, head and neck cancer, ovarian, cervical, endometrial, triple negative breast cancer, and esophageal squamous cell carcinoma who have shown disease progression after recent treatments. The study has two main parts a Phase 1 dose escalation phase to find the maximum tolerated or recommended dose using a Bayesian design, and a Phase 2a dose expansion phase at that recommended dose to confirm safety and observe preliminary anti-tumor effects. Participants receive 177Lu-BetaBart through intravenous infusions every six weeks. Each phase includes a screening period, treatment and imaging period, and a safety and long-term follow-up period to closely monitor outcomes and side effects. During the study, participants undergo assessments including imaging for disease evaluation, laboratory tests for organ function and drug effects, and monitoring of side effects for up to 30 weeks. Key outcomes include determining the suitable dose for future studies, tracking adverse events, and measuring anti-tumor activity through objective response rates and biochemical responses in prostate cancer. Pharmacokinetics, radiation dosimetry, and biokinetics of the drug are also measured at specified time points. Safety and tolerability are evaluated continuously, with follow-up to monitor long-term effects and overall health.

Researchers are evaluating how well 177Lu-DOTATATE works to treat patients with stage IV or recurrent breast cancer that shows evidence of a protein called SSTR2. This phase II study explores whether this targeted therapy can shrink or destroy tumors and circulating cancer stem cells in the blood. 177Lu-DOTATATE combines a radioactive agent with DOTATATE, which attaches to tumor cells with SSTR2 to deliver targeted treatment. Participants receive 177Lu-DOTATATE intravenously over 30 to 40 minutes during weeks 1, 8, 16, and 24 if their disease does not progress and they do not experience unacceptable side effects. Before treatment, patients undergo imaging with gallium 68-DOTATATE PETCT scans and biopsies as needed. Throughout the study, patients have CT or MRI scans and blood samples collected to monitor disease and treatment effects. After completing the treatment phase, participants are followed every 3 months for up to 5 years. The research team measures tumor response, disease control, duration of treatment effect, progression-free survival, and treatment safety. Blood tests, imaging, and biopsies help track how well the therapy works and any side effects, supporting long-term monitoring of patient health.

Researchers are studying patients with Luminal A and estrogen receptor-positive ER-positive lobular breast cancer to evaluate a new imaging method. This study aims to assess the use of hybrid PETMRI combined with a radiolabeled form of estrogen called 16-alpha-18F-fluoro-17-beta-estradiol FES for accurate, non-invasive staging of these breast cancers. The study focuses on comparing this imaging techniques ability to detect cancer spread in axillary lymph nodes with the results from axillary surgery. Participants will undergo a single cohort study where they receive primary surgery as their first treatment. Before surgery, they will have an FES PETMRI scan using the radiotracer FES to capture detailed images of their cancer. Selected patients with heterogeneous tumors on imaging will also have further analysis through pathology, imaging, genomic, and radiomic studies to explore tumor characteristics. Throughout the study, participants will be monitored for the sensitivity of the FES PETMRI in detecting axillary lymph node metastases. Researchers will collect imaging data before surgery and compare it with surgical findings. The study involves no masking or placebo and will follow patients from enrollment until after surgery to gather diagnostic performance data. The total study period extends until 2029, with primary outcome assessment planned around 50 days after imaging.

Researchers are evaluating the potential usefulness of 18F-FAPI-04 positron emission tomographycomputed tomography PETCT and positron emission tomographymagnetic resonance imaging PETMR for diagnosing primary and metastatic cancer lesions, detecting recurrence, and assessing pathological response across various cancer types. The study is observational and aims to assess how well these imaging methods perform compared to standard diagnosis using histopathology and follow-up. Participants with different types of cancer undergo imaging with 18F-FAPI-04 PETCT and PETMR scans. The tracer 18F-FAPI-04 is injected into patients before the scans. Tumor uptake is measured by maximum standard uptake value SUVmax and tumor to background ratio TBR. The imaging results are compared using sensitivity, specificity, positive predictive value, negative predictive value, and accuracy to evaluate diagnostic performance. During the study, participants are assessed through these imaging procedures to monitor tumor presence, recurrence, or response to treatment. The primary outcome is the diagnostic performance evaluated over one year. The study includes participants aged 18 to 90 years and involves informed consent and ethical approval. The total duration and follow-up details are based on imaging and clinical evaluations to confirm findings.

Researchers are evaluating the use of 18F-FDG PETCT imaging to detect breast cancer metastases that conventional imaging methods like CT and bone scintigraphy might miss. This study focuses on women diagnosed with stage IIIII or locoregional recurrent breast cancer, aiming to see if this imaging can improve disease staging and influence treatment decisions. It also explores how imaging and molecular characteristics may relate to patient outcomes such as overall survival and progression-free survival. Participants will undergo an 18F-FDG PETCT scan in addition to the usual CT and bone scintigraphy imaging as part of their cancer assessment. The study includes patients with newly diagnosed high-risk breast cancer or suspectedproven locoregional recurrent breast cancer. The main goal is to determine if the PETCT scan leads to changes in staging or treatment plans compared to conventional imaging alone. During the study, researchers will collect imaging data, including PET parameters and CTMRI measurements, as well as blood and tumor samples for molecular analysis. They will monitor changes in cancer staging and management over five years, along with overall survival. Participants health status will be assessed using the ECOG performance scale, and safety and outcomes will be followed throughout the study period, which runs until 2032.

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 18F-grazy-02 PETCT imaging to study its safety and usefulness in monitoring immunotherapy treatments for patients with lymphoma or solid tumors, including lung cancer and melanoma. This diagnostic trial involves adults aged 18 to 75 years and focuses on immunotherapy approaches such as immune checkpoint inhibition and CAR-T cell therapy. The study is conducted in an open-label format, meaning both researchers and participants know the treatment being administered. Participants will receive an intravenous injection of 18F-grazy-02 at a dose of 2.96-3.7 MBqkg body weight. After injection, a total-body PETCT scan using a uEXPLORER scanner will be performed to image granzyme B expression. This imaging process occurs during the study period, which includes phases 1 and 2, to assess both safety and early monitoring capability of this tracer with immunotherapy. During the trial, participants will undergo PETCT imaging procedures and clinical monitoring to assess adverse events and biodistribution of 18F-grazy-02 over one year. The study also evaluates the ability of this PET tracer to monitor immunotherapy responses over a longer period of three years. Participants will be assessed for their health status, including ECOG performance score and ability to complete imaging procedures. The total study duration extends until December 2028, ensuring comprehensive safety and clinical data collection.