Middletown Township

This research aims to evaluate the use of PET scans with two different radiotracers, FDG and FDHT, in men with progressive prostate cancer. The study focuses on whether these scans can better detect areas where the cancer may have spread in the body. It builds on earlier findings that changes in FDG uptake relate to cancer progression and treatment response, and now investigates FDHT, which targets the androgen receptor in prostate cancer. Participants will undergo PET scans using FDHT alone or both FDG and FDHT based on clinical questions. Scans will take place at baseline, 4 weeks, 12 weeks, and then every 12 weeks for up to one year, with a maximum of 8 scan sets per year and 40 over a lifetime unless otherwise directed. Some patients may have blood draws to study how FDHT moves through the body and may have an initial dynamic scan followed by a standard whole-body PET scan. During the study, researchers will assess where and how much FDHT accumulates in tumors, comparing these findings with other imaging like bone scans, CT, and MRI at baseline, 4 weeks, and 12 weeks. They will also monitor kinetics and metabolism of the tracer, changes over time, and correlations with disease markers and tissue analyses. The study involves repeated imaging and blood tests to better understand prostate cancer progression and response to treatment.

Researchers are evaluating the safety, efficacy, and optimal dosing of a combination of two investigational treatments, BNT323 trastuzumab pamirtecan and BNT327 pumitamig, in people with advanced breast cancer. This includes those with hormone receptor-positive or -negative, HER2-positive, HER2-low, HER2-ultralow, HER2-null breast cancer, or triple-negative breast cancer. The study is a Phase III multi-site, open-label trial with a focus on advanced breast cancer treatment options. The study has two parts. Part 1 involves dose escalation of BNT323 combined with BNT327 to determine the recommended Phase 2 dose using six different dose levels. Part 2, which begins after Part 1 completion, includes dose optimization and exploratory cohorts. Cohort 1 in Part 2 uses randomization into four treatment arms, including combination therapy at different doses and monotherapies of either BNT323 or BNT327. Other cohorts receive the recommended dose without randomization. Participants will undergo assessments including tumor scans and cardiac function tests, with monitoring for side effects and tumor response up to 36 months. Researchers will track dose-limiting toxicities and treatment-emergent adverse events during early treatment cycles and monitor objective response rates and disease control over time. Safety and efficacy data will be collected through scheduled visits and tumor assessments during and after treatment to evaluate the study drugs effects and tolerability.

Researchers are evaluating whether a high-fiber plant-based diet HFPBD can improve quality of life for people with clonal hematopoiesis CH. This diet mainly includes plant foods such as fruits, vegetables, nuts, beans, and whole grains. The study measures quality of life using questionnaires and surveys filled out by participants. Participants will be randomly assigned to one of two groups. One group will receive high-fiber plant-based meals delivered to their homes for 12 weeks and have regular phone or video calls with a dietitian every 2 weeks for the first 12 weeks, every 4 weeks from weeks 13 to 24, and every 8 weeks from weeks 25 to 52. The other group will receive usual care with phone calls every 4 weeks for the first 12 weeks and dietitian calls at weeks 13 and 53. During the study, participants will complete quality of life surveys using the EORTC QLQ C30 questionnaire. Assessments include phone or video visits with dietitians, dietary intake monitoring, and adherence to the assigned diet. The main outcome is improvement in quality of life within the first 12 weeks. The total study duration for participants is 52 weeks, with ongoing monitoring and support throughout this time.

Researchers are investigating whether a dietary intervention can influence treatment response and quality of life in people with newly diagnosed multiple myeloma undergoing standard induction chemotherapy with daratumumab or isatuximab, lenalidomide, bortezomib, and dexamethasone DRVd. The study aims to assess the effects of diet on quality of life, treatment response, and various disease, microbiome, and immune markers by having participants complete questionnaires and other evaluations. Participants are randomly assigned to one of two groups. One group receives usual care, which includes standard chemotherapy and phone calls every 4 weeks with study staff and a dietitian consultation at the end of chemotherapy. The other group receives an intervention with nutrition counseling and coaching, including biweekly dietitian calls for 12 weeks and high-fiber plant-based frozen meals shipped weekly for 12 weeks. Optional group sessions and text message reminders are also provided. Both groups complete dietary and quality of life surveys during the study. During the study, participants complete questionnaires measuring quality of life and dietary intake. Researchers will evaluate the rate of minimal residual disease negative complete response at one year and compare quality of life improvements between groups. Phone or video calls with dietitians and study staff support participant engagement. The study lasts through four 28-day chemotherapy cycles with follow-up assessments up to one year to monitor treatment and quality of life outcomes.

Researchers are evaluating the long-term safety, tolerability, and lasting effects of ALKS 2680 tablets in adults with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This study is an open-label extension designed to continue monitoring participants who completed earlier ALKS 2680 parent studies, focusing on treatment durability and adverse events over an extended period. Participants receive ALKS 2680 oral tablets in doses ranging from 4 mg to 18 mg once daily. The study includes groups with Narcolepsy Type 1, Narcolepsy Type 2, and Idiopathic Hypersomnia. Treatment effects and safety are observed for up to 100 weeks, with dosing adjusted as needed. The study follows a non-randomized, open-label design without blinding. During the study, participants undergo regular assessments including monitoring of treatment-emergent adverse events, measurement of sleep latency using the Maintenance of Wakefulness Test, and evaluation of daytime sleepiness via the Epworth Sleepiness Scale. The total participation duration extends up to approximately 100 weeks, with safety, tolerability, and treatment effects closely tracked throughout this period.

Researchers are evaluating whether telehealth music therapy can be a practical treatment for cognitive difficulties in adults who have survived blood cancers such as lymphoma, leukemia, or myeloma. The study also examines if music therapy and music education can help improve cognitive function as well as symptoms like anxiety, depression, and fatigue in this population. This pilot trial is exploring these effects in hematologic cancer survivors who experience cancer-related cognitive dysfunction. Participants will be assigned to one of three groups the experimental music therapy MT group, the therapist-attention music education TAME control group, or a wait-list control WLC group receiving usual care. Those in the MT and TAME groups will receive 12 weekly 60-minute sessions, with homework assignments between sessions to reinforce skills and concepts. The WLC group completes assessments during a 24-week wait period and can later choose to receive either the MT or TAME intervention. During the study, participants will complete assessments to measure the feasibility of telehealth music therapy, defined by completing at least 9 of the 12 sessions. Researchers will monitor cognitive function, mood symptoms, and fatigue. Participants must be able to complete study assessments independently and consent in English. The total study duration includes the intervention period and follow-up assessments to evaluate outcomes related to cancer-related cognitive dysfunction.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of HBS-301 in adults aged 18 years and older with narcolepsy. The study focuses on treating excessive daytime sleepiness EDS, cataplexy, sleepinesswakefulness, and fatigue in participants diagnosed with narcolepsy. Approximately 258 participants will be included in this trial. Participants will be randomly assigned to receive either HBS-301 tablets or matching placebo tablets once daily in the morning upon waking. The study includes a ScreeningBaseline period lasting up to 28 days, followed by an 8-week Double-blind Treatment period. After this, participants may choose to enter a 1-year Open-label Extension period where they will receive HBS-301. Finally, a 30-day safety follow-up will monitor participants after treatment ends. Throughout the study, participants will undergo various assessments including evaluations of daytime sleepiness using the Epworth Sleepiness Scale, cataplexy frequency, wakefulness through the Maintenance of Wakefulness Test, fatigue levels, cognitive complaints, quality of life, and work productivity. Safety will be monitored by tracking adverse events and pharmacokinetic measurements. The total study participation may last up to approximately 16 months including all phases.

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who have agitation related to Alzheimers Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to address agitation symptoms in this population by comparing the investigational drugs with a placebo. The study is sponsored by Bristol-Myers Squibb and uses established diagnostic criteria for Alzheimers Disease. Participants will receive either the combination of XanomelineTrospium Chloride capsules KarXT KarX-EC or a placebo with specified doses on designated days. The study includes a parallel group design and treatment lasts for 14 weeks. The main focus is to assess changes in agitation using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association CMAI-IPA total score. During the study, participants will undergo regular assessments including cognitive and behavioral evaluations, safety monitoring through vital signs, laboratory tests, electrocardiograms, and rating scales for movement disorders and suicidal ideation. Caregivers will be involved to help monitor participant status and medication compliance. The primary outcome is measured at Week 14, with safety follow-up extending to Week 18. Participants are expected to be engaged throughout the treatment period and follow-up assessments.

Researchers are studying patients with Stage I lung cancer who are undergoing planned pulmonary segmentectomy surgery. The study aims to understand the disease-free survival rates at 3 and 5 years after this surgery in people suitable for this procedure based on clinical staging. Patients with suspected non-small cell lung cancer are included, even if tissue diagnosis is not confirmed before surgery. Participants in this observational study complete questionnaires using the Patient-Reported Outcomes Measurement Information System PROMIS, which evaluates physical function, pain interference, and breathing difficulty. These questionnaires are completed before surgery, between 2 to 4 weeks after surgery, and again 6 months after surgery. The study collects data through this web-based platform developed by the National Institutes of Health. During the study, participants are asked to fill out surveys at specified times to assess their health and symptoms. Researchers will track disease-free survival over 3 and 5 years after surgery to evaluate outcomes. Participation involves completing questionnaires and follow-up over several years, with no investigational treatment being administered. The total study completion is expected by May 2029.

Researchers are collecting detailed information in a registry to better understand various types of mature T-cell and natural killer NK-cell lymphomas. This observational study aims to improve knowledge about these rare blood cancers by creating a comprehensive database that includes clinical information and tumor samples from participants. The study is sponsored by Memorial Sloan Kettering Cancer Center and focuses on multiple specific T-cell lymphoma subtypes as defined by recognized classification guidelines. Participants with confirmed mature T-cell or NK-cell lymphoma may choose to provide optional blood and nail samples for future research and biobanking. The study does not involve experimental treatments but gathers data prospectively from individuals meeting strict diagnostic criteria, including those receiving systemic therapy for certain cutaneous lymphoma types. This approach supports long-term data collection rather than testing new therapies. During the study, participants will have clinical data and tumor specimens collected and recorded. Researchers will track the number of participants contributing to the T-cell Lymphoma Master Repository over a 10-year period. The study involves ongoing follow-up to measure disease status and treatment response, with no direct intervention required. Participation helps build a resource to advance future research and understanding of these lymphomas.