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Researchers are investigating CGT9486, also known as bezuclastinib, in an open-label Phase 2 study for patients with Advanced Systemic Mastocytosis AdvSM. This includes those diagnosed with Aggressive Systemic Mastocytosis ASM, Systemic Mastocytosis with an Associated Hematologic Neoplasm SM-AHN, and Mast Cell Leukemia MCL. The study aims to evaluate the safety, effectiveness, pharmacokinetics, and pharmacodynamics of bezuclastinib in this patient population. Participants will receive bezuclastinib tablets orally, taken continuously in 28-day cycles. The study is divided into two parts Part I focuses on identifying effective and tolerable dosing exposures over 18 months, while Part II evaluates the drugs efficacy by measuring objective response rates and confirming the exposure-response relationship, also over 18 months. Additional assessments include effects on mutation allele burden, serum tryptase levels, histopathologic changes, spleen and liver volume, and safety monitoring. During the study, participants will undergo various clinical evaluations, including laboratory tests, imaging to monitor organ size changes, and assessments of disease response and progression. Researchers will track adverse events and pharmacokinetic profiles throughout the 18 months. The study involves continuous monitoring of participants to understand the treatments impact on survival and disease progression over this period.

Researchers are evaluating the safety and effectiveness of elenestinib BLU-263 combined with symptom directed therapy SDT compared to placebo plus SDT in adults with indolent systemic mastocytosis ISM whose symptoms are not well controlled by SDT alone. This randomized, double-blind, placebo-controlled Phase 23 study includes multiple parts to assess different doses and durations of elenestinib treatment, including an open-label extension for participants finishing earlier phases. The study also enrolls participants who have previously received an approved selective KIT inhibitor and includes pharmacokinetic groups. Participants receive oral elenestinib or placebo once daily alongside SDT, which is personalized based on individual symptom management needs. Part 1 focuses on short-term treatment lasting up to 12 weeks, while Part 2 extends treatment to approximately 48 weeks. Part 3 and other parts allow treatment for up to about 5 years. The study monitors participants through these phases to evaluate how elenestinib affects symptoms, disease markers, and safety over time. During the study, participants undergo regular assessments of symptoms using the ISM-Symptom Assessment Form ISM-SAF, laboratory tests including serum tryptase and KIT D816V allele levels, bone marrow evaluations, and quality of life measures. Researchers track adverse events and changes in disease-related factors at various points up to 5 years. This thorough monitoring helps measure treatment effects and safety over both short and long-term periods, with total participation lasting several years depending on the study part.

Researchers are evaluating the combination of CGT9486 and sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors GIST. This Phase 3, open-label international trial involves multiple parts, including dose confirmation, drug interaction assessments, and efficacy comparisons. The study also includes substudies focusing on drug-drug interaction potential and first-line treatment in patients with specific genetic mutations KIT exon 9. Approximately 482 patients will participate across these parts.

Researchers are evaluating if 18F-FAraG PET scans can detect tumors in people with esophageal cancer and predict how they respond to chemoradiation treatment. This phase 1 study aims to assess the imaging tracers ability to identify cancer and forecast complete pathologic response, along with correlations with clinical features, tissue and blood biomarkers, and survival outcomes. Participants will receive a 18F-FAraG PET scan before starting their standard treatment. About 20 minutes before the scan, they will drink water to help clear the tracer from their kidneys. The tracer is given by intravenous injection. Standard imaging will also be done before treatment begins to compare with the research scan. During the study, researchers will monitor safety and adverse events for about one year. Participants will undergo the 18F-FAraG PET scan and standard imaging to evaluate tumor detection and treatment response. Blood and tissue samples may be collected to study biomarkers. The study tracks overall and disease-free survival as part of the long-term follow-up.

Researchers are evaluating the use of the radiopharmaceutical 18F-mFBG as an imaging agent to measure how neurodegenerative diseases affect the hearts sympathetic nervous system, particularly in people with Lewy body diseases like Parkinsons disease and Lewy body dementia. This Phase 2 study aims to compare 18F-mFBG imaging results between subjects with Lewy body disease and those with non-Lewy body neurological diseases, using historical data from healthy individuals for reference. The study addresses challenges in current imaging techniques and explores improved methods for quantifying myocardial sympathetic innervation. Participants will receive an intravenous injection of 222-370 MBq 6-10 mCi of 18F-mFBG. Imaging will be performed twice a whole-body scan from the head to the pelvis will be done 30 minutes after injection, and a static image of the chest area will be taken at 60 minutes. The study includes two groups one with known or presumed Lewy body disease and another with neurological diseases not related to Lewy bodies. Both groups undergo the same imaging procedure. Throughout the study, participants will undergo PETCT or PETMR scans to assess the extent and regional reduction of 18F-mFBG uptake in the heart and whole body. Researchers will analyze quantitative imaging data to distinguish differences between the groups. The study duration for outcome measurements is up to six months, during which participants remain clinically stable. Safety and imaging effectiveness will be carefully monitored, with the total study completion expected by December 2026.

Researchers are evaluating the radiopharmaceutical 18F-meta-fluorobenzylguanidine 18F-mFBG as a new imaging agent to measure myocardial sympathetic innervation in stable patients with heart failure due to ischemic cardiomyopathy. This Phase 2 study focuses on adults who have a left ventricular ejection fraction of 35% or less and have implantable cardioverter-defibrillators ICDs. The study aims to compare 18F-mFBG uptake with historical imaging agents and assess differences in sympathetic innervation related to past ICD activations. Participants will receive two PET radiopharmaceuticals intravenously 18F-mFBG to assess sympathetic innervation and Rubidium-82 to assess myocardial blood flow. The study groups consist of patients who have experienced ICD activation within the past 12 months and those who have not. Both imaging agents will be used to examine cardiac regions for abnormalities and to quantify myocardial uptake patterns during the study. During the trial, participants will undergo PET imaging and safety monitoring for 24 hours after the administration of these agents. Researchers will collect imaging data, evaluate heart function, and monitor for any adverse or serious adverse events. The study will assess how well 18F-mFBG works compared to previous imaging methods and gather safety information over the course of participation.

Researchers are studying the use of a 2,910 nm mid-infrared Fiber Laser UltraClear, Acclaro Medical to treat advanced perioral lines and wrinkles. The goal is to assess the lasers effectiveness for skin rejuvenation by using both superficial epidermis ablation and deeper skin layers ablative and coagulative effects. The study also aims to evaluate safety and participant satisfaction with this resurfacing treatment for photodamaged skin and wrinkles. Participants will receive up to two treatments with the UltraClear laser, spaced 6 to 8 weeks apart. These treatments focus on improving the appearance of perioral lines and wrinkles using the lasers combined superficial and deep skin effects. Following treatments, participants will have follow-up visits at 1 month and 3 months to evaluate the results and any side effects. Throughout the study, researchers will measure improvements using multiple scales, including the Fitzpatrick Wrinkling and Degree of Elastosis Scale, Physician Global Aesthetic Improvement Scale, and assessments by independent photographic reviewers. Participants will also report their own perceptions of aesthetic improvement and satisfaction. Safety and overall aesthetic outcomes will be monitored during follow-ups, with the total participation lasting through the 3 months after the final treatment.

Researchers are evaluating advanced radiation treatment techniques, specifically stereotactic body radiation therapy SBRT, for safely delivering a strong dose of radiation to tumors in patients with head and neck squamous cell carcinoma HN SCC who are not eligible for curative treatment. The trial aims to compare local progression-free survival, pain response, symptom burden, toxicity, local control, progression-free survival, and overall survival between SBRT and traditional radiation methods. This Phase II randomized trial explores if SBRT can provide effective palliation in a shorter treatment period than conventional approaches. Participants will be randomly assigned to receive either traditional radiation therapy or SBRT. Both treatments involve radiation delivered according to schedules discussed with the study doctor. The study focuses on comparing these two radiation methods for palliation in patients with HN SCC. Treatment details, including timing and dosage, will be managed individually by the medical team. The trial runs until September 2027, with treatment and follow-up planned over about one year. During the study, participants undergo evaluations such as symptom assessments using the M. D. Anderson Symptom Inventory for head and neck cancer MDASI-HN, pain scoring, quality of life questionnaires, and clinical examinations including imaging like CT, MRI, or PETCT scans. Baseline symptoms, smoking history, and pregnancy status for women of child-bearing age are checked before randomization. Researchers will monitor symptom burden and treatment responses throughout the trial, with data collection continuing for up to one year after treatment. Informed consent and regular clinical assessments support participant safety and data accuracy throughout the study.

Researchers are investigating treatments for patients with metastatic colorectal cancer who have not responded to second-line therapy. This randomized phase II trial compares the combination of 5-fluorouracilleucovorin 5FULV with regorafenib against a combination of trifluridine-tipiracil FTD-TPI plus bevacizumab. The study aims to evaluate the effectiveness and safety of these treatments in this third-line setting. Participants are randomly assigned in a 21 ratio to one of two groups. The first group receives 5FULV given intravenously in two-week cycles along with regorafenib taken orally daily with dose escalation over three weeks followed by one week off, continuing up to 12 cycles or until disease progression. The second group receives FTD-TPI orally twice daily on specific days of a 28-day cycle and bevacizumab intravenously on days 1 and 15, also continuing up to 12 cycles or until disease progression or unacceptable side effects. During the study, participants will undergo regular assessments to monitor treatment effects and safety. Researchers will track the time from treatment start until disease progression, unacceptable toxicity, or withdrawal, assessing up to 18 months. Safety and tolerability will also be evaluated. The trial includes laboratory tests and clinical evaluations throughout the treatment period, with the possibility to withdraw at any time. Total participation duration depends on individual treatment response and tolerance.

Researchers are evaluating the use of XYOSTED as a testosterone replacement therapy in adolescent males aged 12 to under 18 years with primary or secondary hypogonadism, a condition where the body produces little or no testosterone. This Phase 34 open-label study aims to assess how well XYOSTED supports the continuation or start of puberty, along with its safety and the testosterone levels it maintains. Participants will receive XYOSTED injections at doses tailored to their weight and targeted pubertal stage. Dose adjustments will be made based on testosterone levels measured at specific intervals after dosing, with evaluations approximately every three months to reach the desired hormone levels. After completing the 52-week initial study period, participants may enter a 24-month extension to further monitor long-term safety and treatment effects. Throughout the study and extension, participants will undergo clinical examinations including pubertal staging, blood tests for testosterone and other labs, bone density scans, body composition assessments, and X-rays to monitor bone age. Researchers will track changes in puberty progression, bone health, body measurements, and hormone levels. Participants will attend regular clinic visits every six months during the extension phase to continue safety and pharmacokinetic evaluations.