Medullary Thyroid Carcinoma

Researchers are evaluating 177Lu-CTR-FAPI, a new radiopharmaceutical, for treating thyroid cancer in a multi-center, open-label phase I trial. The study aims to determine the safety, tolerability, and preliminary effectiveness of this treatment, focusing on dose-limiting toxicities to find the maximum tolerated dose. The research also assesses biochemical and radiological responses, quality of life improvements, and the dosimetry profile of 177Lu-CTR-FAPI. Participants will receive intravenous infusions of 177Lu-CTR-FAPI every 6 weeks for up to 4 cycles. The dosing starts at 100 mCi and increases by 50 mCi increments following a standard "3+3" dose-escalation design. Dose delays are allowed based on treatment response or recovery needs, with a maximum delay of 12 weeks after the previous dose. Vital signs and adverse reactions will be closely monitored during infusions. During the study, participants will undergo assessments including biochemical and radiological evaluations, quality of life and pain score measurements, and dosimetry scans to measure radiation absorbed by organs and tumors. The primary outcome focuses on safety and dose-limiting toxicities within 6 weeks after the first injection. Secondary outcomes include response rates, survival, and quality of life changes up to one year after the last treatment. Overall, the trial involves close monitoring and evaluation over several months to understand the treatment's safety and impact.

Researchers are evaluating the safety and effectiveness of a new molecular probe called 18F-FAPI-YQ104, which targets fibroblast activation protein (FAP), for early tumor diagnosis. This observational study focuses on patients with lung cancer, pancreatic cancer, neuroendocrine tumors, and thyroid cancer. The goal is to verify how well this probe works in detecting tumors during clinical use. Participants will receive an intravenous injection of the 18F-FAPI-YQ104 probe followed by a PET-CT examination to capture detailed images of tumor lesions. The study will observe the probe's uptake in tumor sites, measured by SUVmax values 60 minutes after administration. No additional treatment is given; instead, the study monitors the imaging results to assess the probe's diagnostic potential. During the study, participants will undergo PET-CT scans and other imaging tests such as CT or MRI. Researchers will evaluate the images to measure tumor activity and probe uptake. Safety assessments include checking kidney and liver function, blood counts, and monitoring for allergic reactions. The study will last from April 2025 to March 2026 and includes adults aged 18 to 75 years who have confirmed tumors and meet health criteria.

This research aims to evaluate the use of a specialized imaging technique called 68Ga-labeled targeted covalent radiopharmaceutical (TCR) fibroblast activation protein inhibitor (FAPI) PET/CT to guide surgery for medullary thyroid carcinoma (MTC). Surgery is currently the only curative option for MTC, but existing imaging methods and calcitonin tests are not sufficient to fully map the disease. This study focuses on whether 68Ga-TCR-FAPI PET/CT can better identify the extent of MTC and improve surgical planning. Participants are divided into three groups: those newly diagnosed with MTC, those with recurrent or persistent MTC after prior treatment, and those with distant or unresectable lesions but still recommended for surgery. Surgery will be performed based on the lesion range revealed by the 68Ga-TCR-FAPI PET/CT scan, aiming to remove all identified lesions when possible. The surgical principles follow current standards, including lymph node dissection when needed. During the study, researchers will measure calcitonin levels one month after surgery as the primary outcome. Secondary outcomes include two-year event-free survival, how often surgical plans change based on imaging results, and the accuracy of 68Ga-TCR-FAPI PET/CT in detecting MTC lesions. Participants will undergo PET/CT scans, surgery guided by imaging findings, and follow-up assessments to monitor outcomes and safety up to two years after surgery.

Researchers are evaluating the benefits and risks of prophylactic central lymph node dissection in patients with low-risk papillary thyroid carcinoma (PTC), specifically in those with primary tumors classified as cT1b-T2N0. PTC is the most common thyroid cancer, usually treated with surgery, but the need for removing lymph nodes that do not show obvious cancer involvement remains unclear. This study aims to clarify whether routine removal of these lymph nodes improves treatment response, reduces recurrence, and helps guide decisions about radioactive iodine therapy, while considering the risk of complications. The study randomly assigns participants to one of two groups: one group undergoes prophylactic central neck dissection on the side of the lesion, and the other group does not receive central neck dissection. Surgery is the primary intervention, and the trial is open-label and multicenter. The study includes adult patients aged 18 to 70 years with specific tumor sizes and no suspicious lymph nodes detected before surgery. Participants will be followed for at least one year to assess treatment response, measured by excellent response rates, and recurrence-free survival at one and two years. Assessments include monitoring thyroglobulin and its antibodies to evaluate short-term treatment outcomes. Study visits and follow-up tests will help track disease status and safety. The total participation duration is expected to cover these time points, supporting evaluation of long-term benefits and risks of the surgical approach.

Researchers are evaluating AL2846, a multi-target tyrosine kinase inhibitor, in adults with locally advanced or metastatic differentiated thyroid cancer that no longer responds to iodine treatment and has progressed after previous VEGFR-targeted therapies. This Phase III trial aims to see if AL2846 can extend the time patients live without their cancer worsening compared with a placebo. The study is led by Chia Tai Tianqing Pharmaceutical Group and involves random assignment to treatment groups with both patients and investigators unaware of the assignments. Participants will receive either AL2846 capsules or a placebo in 28-day treatment cycles. The AL2846 drug targets specific receptors involved in tumor growth, including c-MET, c-KIT, VEGFR1, and RET. The study will last up to 34 months, during which patients will be monitored for disease progression, response rates, survival, and safety. Both groups follow the same cycle length to compare outcomes fairly. Throughout the trial, participants will undergo regular assessments including imaging scans to measure tumor size, blood tests to monitor health status and safety, and evaluations by an independent review committee and researchers. Researchers will track progression-free survival as the main outcome, along with overall survival, response rates, and duration of response. Safety of AL2846 compared to placebo will also be closely monitored. Participants' involvement may last up to nearly three years, allowing for detailed observation of treatment effects and tolerability.

Researchers are evaluating whether the combination of avutometinib and defactinib can effectively treat people with RAF dimer-driven radioiodine-refractory differentiated thyroid cancer or anaplastic thyroid cancer. The study also aims to determine if these treatments are safe and cause only mild side effects. This is a Phase II clinical trial sponsored by Memorial Sloan Kettering Cancer Center. Participants receive treatment with avutometinib at 3.2 mg twice weekly and defactinib at 200 mg twice daily, following a schedule of three weeks on treatment and one week off. Two groups are included: one with radioiodine-refractory differentiated thyroid cancer, and another with anaplastic thyroid cancer, both having specific genetic alterations. The study does not involve randomization or blinding. Throughout the study, participants will be monitored for their overall response rate up to two years. Researchers will assess tumor response, side effects, heart function, laboratory tests, and genetic markers. Participants must undergo biopsies for research, provide tissue samples, and attend regular visits for evaluations. The study continues until disease progression or unacceptable side effects occur, with ongoing safety monitoring.

Researchers are collecting information on the use of redifferentiating medications as a standard treatment for patients with radioactive iodine (RAI)-refractory thyroid cancer. This study is a registry designed to learn more about how these medications are used in routine clinical care for this condition. It is an observational study focused on patients who have thyroid cancer that does not respond well to RAI treatment. Participants will undergo follow-up visits at intervals determined by their usual clinical care. During these visits, researchers will record how well patients tolerate the redifferentiating medications and any adverse events they experience. The study includes patients receiving these agents as part of their regular treatment, both prospectively and retrospectively, but excludes those receiving such agents within other clinical trials. Participants will be monitored for adverse events at every visit over a period of two years. Researchers will collect and review data on medication tolerance and side effects during these follow-up appointments. This ongoing observation aims to provide a clearer picture of outcomes for patients treated with redifferentiation agents in usual care settings.

Researchers are evaluating the safety and effects of the study medicine PF-07799544, alone or combined with another medicine called PF-07799933, as a potential treatment for adults with advanced solid tumors that have a BRAF V600 mutation. This clinical trial includes two parts: Phase 1a testing PF-07799544 alone and Phase 1b testing PF-07799544 together with PF-07799933. Phase 1a is closed for enrollment, and Phase 1b focuses on participants with metastatic or recurrent solid tumors, excluding colorectal cancer, who have received prior cancer treatments. In this study, all participants receive both PF-07799544 and PF-07799933 as oral tablets taken twice daily at home. Treatment continues until the cancer stops responding, unacceptable side effects occur, or up to two years, with the option to continue beyond two years. The trial is designed to observe the experiences of participants using these medicines to assess safety and treatment effects. Participants will be monitored through regular assessments including evaluations of side effects, laboratory tests, vital signs, and physical exams from the start of treatment until 28 days after stopping the study drugs. The main measure is to track dose-limiting toxicities within the first 21 days of treatment cycles and overall response rate up to two years. Additional monitoring includes treatment-emergent adverse events, changes in lab results and vital signs, and pharmacokinetics to understand how the drugs behave in the body.

Researchers are studying the safety and effects of a medicine called PF-07799933 for people 16 years and older who have advanced solid tumors with a specific abnormal gene called BRAF. This study focuses on participants whose cancers have progressed despite available treatments. It is a phase 1, open-label trial sponsored by Pfizer to evaluate the tolerability, pharmacokinetics, and anti-tumor activity of PF-07799933 alone and in combination with other medicines. All participants will receive PF-07799933 tablets twice daily. Depending on the tumor type, some may also receive other study medicines: binimetinib tablets twice daily for melanoma or other solid tumors; or cetuximab injections weekly or every two weeks, alone or combined with chemotherapy (mFOLFOX6), for colorectal cancer. The study includes dose escalation and expansion parts to assess different combinations and doses. Participants may receive treatment for about two years with regular clinic visits for monitoring. Researchers will assess side effects, laboratory results, vital signs, physical exams, and tumor responses over time. They will also study how the drug is processed in the body. The study monitors dose changes, interruptions, and discontinuations related to treatment-emergent adverse events, aiming to understand safety and effectiveness in this patient group.

Researchers are investigating the use of ablation combined with lenvatinib and a PD-1 inhibitor for advanced hepatocellular carcinoma (HCC) with oligometastasis. This study explores a subtype of metastatic HCC where there are limited metastases, aiming to evaluate whether removing these metastases can improve survival. The trial is a multicenter, prospective, phase II study focused on the safety and effectiveness of this combined approach. Participants receive a treatment combining ablation of oligometastases using microwave ablation, radiofrequency ablation, or cryoablation, along with systemic therapy using lenvatinib and PD-1 inhibitors. Ablation targets metastases limited to five sites in no more than two organs, each measuring up to 5 cm. Patients must have already received at least 3 months of lenvatinib and PD-1 inhibitor therapy with controlled intrahepatic tumors before ablation. Throughout the study, participants will be monitored for progression-free survival over 24 months as the primary outcome. Additional assessments include overall survival, objective response rate, and adverse events within 12 to 24 months. Researchers will perform regular evaluations to track treatment response and safety, with the total study duration extending to August 2027.