Carcinoma

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 a new radiation treatment for localized prostate cancer using a single high-dose stereotactic body radiotherapy SBRT session. This trial focuses on delivering 24 Gy in one fraction with a technique that spares the urethra, aiming to reduce side effects while treating the prostate and seminal vesicles. The study is prospective, non-randomized, and conducted at a single center with the goal of assessing safety, toxicity, cancer control, survival, and quality of life over time. The treatment involves implanting fiducials, performing simulation CT and MRI scans, and delivering a single high-dose radiation session similar to high-dose-rate brachytherapy but sparing the urethra. Patients with negative lymph nodes and no distant metastases will receive the radiation dose of 24 Gy in one day. Androgen deprivation therapy ADT will be used for some patients based on risk. Short-term cortisone and alpha-blockers will be given to prevent side effects. The study will enroll up to 70 patients in phases, monitoring toxicity closely before continuing enrollment. Participants will have follow-up visits at 1, 3, 6, 12, 18, 24, 36, 48, and 60 months. These visits include blood tests for prostate-specific antigen PSA and testosterone, imaging as needed, and quality of life questionnaires covering general health, urinary symptoms, sexual function, and prostate cancer-specific issues. The main outcome is measuring acute toxicity one month after treatment, with longer-term monitoring of cancer control, survival, toxicity, and quality of life through five years.

This trial studies a new three-dimensional ultrasound 3D-US imaging technology designed to evaluate lymph nodes in patients with breast cancer. The study aims to optimize the 3D-US performance, assess its ability to differentiate benign from malignant lymph nodes, and compare it with conventional two-dimensional ultrasound methods for locating clipped lymph nodes in patients undergoing neoadjuvant chemotherapy. Participants receive the 3D-US imaging as part of the study. Those with a lymph node clip placed and undergoing chemotherapy will have the clipped lymph node imaged before surgery. This is an early phase I diagnostic study focused on improving imaging techniques for breast cancer lymph node evaluation. During the study, participants undergo 3D-US imaging to assist radiologists in diagnosing whether lymph nodes are benign or malignant. The primary outcome measure is the accuracy of lymph node diagnosis by radiologists over a period of up to two years. The study involves imaging before surgery, with ongoing evaluation of the diagnostic performance of the new technology throughout the study duration.

Researchers are evaluating the use of 68Ga-grazytracer PET imaging to help diagnose pseudoprogression in lung cancer patients after immunotherapy. Pseudoprogression is difficult to distinguish with current clinical methods, which often require follow-up observations that may not meet clinical needs. This study aims to assess the effectiveness and feasibility of this novel imaging agent, which targets granzyme B to show the activity of cytotoxic T cells in tumor areas. This observational study uses 68Ga-grazytracer PETCT scans to visualize and semi-quantitatively measure granzyme B concentration in lung cancer lesions that have enlarged or developed new lesions after immune checkpoint inhibitor treatment. The study follows patients for 4-8 weeks, up to a maximum of 12 weeks, to evaluate the diagnostic performance of this imaging method in detecting pseudoprogression. Participants will undergo PETCT imaging and be monitored over the follow-up period to assess changes and outcomes. Researchers will collect data on diagnostic accuracy and safety during this time. The study includes adult lung cancer patients aged 18 to 75 years who meet specific clinical criteria and have a life expectancy of at least six months. Total participation duration varies with the follow-up period, and patient compliance with study requirements is monitored throughout.

This clinical trial is studying patients with hypoalbuminemia and a new diagnosis of small, early-stage hepatocellular carcinoma HCC. It aims to compare outcomes between two liver-directed treatments to see if 90-Yittrium Therasphere transarterial radioembolization 90Y reduces the risk of disease progression within one year after diagnosis. The focus is on patients with a single tumor 3 cm or smaller and albumin levels below 3.4 gdL at diagnosis. Participants are randomly assigned to receive either 90Y or microwave ablation MWA as their first liver-directed therapy. The 90Y treatment involves a two-phase process including a mapping angiogram with personalized dosimetry followed by infusion of 90-Yittrium glass microspheres targeting the tumor area. The MWA uses a high-powered, gas-cooled multi-antenna system to ablate the tumor with an ablative margin greater than 5 mm. After this initial treatment, participants continue with standard care for early-stage HCC. Throughout the study, participants are followed for one year after their first treatment cycle. Researchers will collect data on adverse events, treatment response, time to any retreatment, duration of response, and disease progression. The main measure is disease progression at one year, with additional evaluations done 60 to 120 days after treatment. This monitoring helps assess the safety and effects of the two treatments over time.

This research aims to study the distribution of a radioactive imaging agent called 99mTc-PSMA-I&S in men with prostate cancer who are undergoing pelvic lymph node dissection. The study focuses on detecting prostate cancer spread by using a special imaging method that targets prostate-specific membrane antigen PSMA in both normal and cancerous tissues. This exploratory study is conducted under a regulatory research program and includes histopathology validation when possible. Participants receive intravenous doses of 99mTc-PSMA-I&S. The first five patients get an initial dose followed by five SPECTCT scans at multiple time points between 3 and 46 hours after injection. These five patients then receive a second dose before standard pelvic lymph node surgery. All other patients receive one dose before their scheduled surgery. The study uses advanced imaging techniques to track the agents accumulation in tissues and aims to find the best timing for surgery based on tumor-to-background ratios. During the study, participants undergo imaging scans and surgery as part of their standard care. Researchers collect data on the radioactive agents presence in tissues using imaging and gamma measurements, alongside examining tissue samples for PSMA expression. The main measurement is the uptake values of the agent in tissues over time. Safety and follow-up are aligned with normal surgical care. The study duration extends up to June 2028, with detailed imaging and surgery scheduling during the treatment period.

Researchers are evaluating the effectiveness of combining 9MW2821 with toripalimab compared to using 9MW2821 alone in patients with locally advanced or metastatic urothelial carcinoma who have not yet received systemic treatment for their advanced cancer. This randomized phase II trial aims to improve first-line treatment options for this condition, which includes urothelial carcinoma of the bladder, renal pelvis, and ureter. Participants will be assigned to receive either the combination of 9MW2821, a nectin-4 antibody-drug conjugate with MMAE payload, plus toripalimab, an anti-PD-1 antibody, or 9MW2821 monotherapy. The study treatments will be given according to protocol, with no masking or blinding. The trial includes a planned 3-year period to assess treatment response and safety. Throughout the study, participants will undergo regular assessments including evaluations of tumor response using RECIST v1.1 criteria, safety monitoring, and immunogenicity tests over three years. Researchers will measure outcomes such as the objective response rate and other efficacy endpoints. Participants must be able to follow study visits, treatment, and laboratory procedures, with contraceptive measures maintained until 180 days after the last dose. The overall participation spans from screening through treatment and follow-up over the study duration.

Researchers are studying the safety and tolerability of increasing doses of 177LuLu-AKIR001, a drug targeting CD44v6-expressing solid tumors that cannot be surgically removed or have spread. This early phase 1 trial focuses on patients with advanced cancers such as thyroid gland anaplastic carcinoma, poorly differentiated thyroid carcinoma, head and neck cancer, cervix carcinoma, vulvar cancer stage IV, and non-small cell lung cancer stage IV, who have no other reasonable treatment options. The main goal is to understand the toxicity profile of 177LuLu-AKIR001 by monitoring dose-limiting toxicities and serious adverse events.

Researchers are studying a new type of scan called FAPI-PETCT to see how well it detects metastases in patients with advanced gastric cancer. The study aims to find out if this scan can better identify cancer spread, leading to changes in treatment plans such as avoiding unnecessary surgeries or shifting to comfort-focused care. It also evaluates whether the scan causes less burden for patients compared to current methods. Participants will receive the standard care for gastric cancer and undergo one additional FAPI-PETCT scan, where a small amount of 18F-FAPI-74 is given intravenously about 60 minutes before a PETCT scan lasting around 20 minutes. The results from this scan will help doctors decide on further tests or surgery needed. The study monitors changes in diagnosis and treatment decisions based on the scan. During the study, participants will complete questionnaires taking about 4 hours total and spend approximately 2 hours for the extra scan. Researchers will measure outcomes such as changes in treatment intent, diagnostic work-up, scan accuracy, incidental findings, patient burden, quality of life, and safety over about one year. Follow-up includes quality of life assessments and cost evaluations at multiple time points after staging.