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 PET/CT 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 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.

Researchers are studying a new three-dimensional ultrasound (3D-US) imaging technology to see how well it evaluates lymph nodes in patients with breast cancer. This early phase I trial aims to improve the 3D-US technology, assess its ability to tell apart benign and malignant lymph nodes, and compare it with the traditional two-dimensional ultrasound (2D-US) method for locating clipped lymph nodes. During the study, patients will undergo 3D-US imaging. Those who have a lymph node clip placed and are receiving chemotherapy before surgery will have the clipped node imaged using the 3D-US technique. This process is designed to help optimize and evaluate the new imaging method. Participants will have their lymph nodes examined by a radiologist to determine if they are benign or malignant, with this evaluation occurring over up to two years. The study involves monitoring and imaging before surgery to gather data on the new technology's performance. The total duration of involvement varies, focusing on the imaging and diagnostic outcomes.

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 PET/CT 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 PET/CT 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 g/dL 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.

Researchers are studying the biodistribution of a radioactive agent called 99mTc-PSMA-I&S in men with prostate cancer who are undergoing pelvic lymph node dissection. This exploratory, early-phase study aims to understand how this agent spreads in normal and cancerous tissues, helping to detect prostate cancer that has spread to lymph nodes. The study also seeks to find the best timing for using this agent during surgery and to correlate imaging results with tissue analysis when possible. The study involves giving an intravenous dose of 99mTc-PSMA-I&S to participants. The first five patients receive an initial dose followed by five SPECT/CT scans at multiple time points over about two days. These patients then get a second dose before standard surgery. All other participants receive one dose before their scheduled surgery. The imaging uses single-photon emission computed tomography combined with computed tomography (SPECT/CT) to detect cancerous lymph nodes. Participants will undergo several imaging scans to track how the radioactive agent distributes in their bodies over time. Researchers will measure uptake values in tissues and compare these with tissue samples analyzed during surgery. The study will assess the best timing for surgery using this agent based on tumor-to-background uptake ratios. The total participation includes imaging visits and standard care surgery, with follow-up limited to the study procedures and data collection.

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 [177Lu]Lu-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 [177Lu]Lu-AKIR001 by monitoring dose-limiting toxicities and serious adverse events.

Researchers are studying a new type of scan called FAPI-PET/CT 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-PET/CT scan, where a small amount of [18F]-FAPI-74 is given intravenously about 60 minutes before a PET/CT 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.

Researchers are evaluating whether a three-dimensional (3D)-printed external breast prosthesis can improve patient-reported outcomes for breast cancer patients who have had a mastectomy without undergoing surgical reconstruction. Breast cancer often requires mastectomy, and while reconstruction is common, some patients choose not to or are not candidates. Traditional external prostheses may lack comfort and proper fit, so this study is assessing a customized 3D-printed prosthesis made using 3D imaging and computer-aided design (CAD). This approach aims to create a better fitting prosthesis which could enhance patient satisfaction and emotional well-being. During the study, patients undergo a CT scan and have a patient-specific external breast prosthesis model developed using CAD. Measurements are taken for the 3D-printed prosthesis during screening. Participants then receive a fitting and are given the 3D-printed external breast prosthesis. The study involves procedures such as CAD development, measurements, prosthesis fitting, and receiving the customized prosthesis. Questionnaires are also administered to assess patient-reported outcomes. Participants will complete assessments at baseline and at 1, 3, 6, and 12 months, including surveys about satisfaction with appearance, emotional well-being, comfort, fit, and overall satisfaction with the 3D-printed prosthesis. Study procedures include surface scanning with temporary skin markers, standardized photography, and follow-up surveys. The study aims to monitor these outcomes over one year to evaluate the impact of the personalized prosthesis on patient experiences after mastectomy.