Thyroid Cancer

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 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 cancer treatment called [212Pb]VMT-Alpha-NET for tumors that have somatostatin receptors (SSTRs) on their surface. These tumors include those found in the lungs, head and neck, digestive tract, kidneys, and adrenal glands. The study focuses on people with tumors that have spread and cannot be removed by surgery. The goal is to find the highest safe dose of this drug and evaluate its safety and effects on these cancers. The treatment involves giving [212Pb]VMT-Alpha-NET through a vein on the first day of each 8-week cycle, for a total of four cycles. Some participants will also receive a related imaging drug, [203Pb]VMT-Alpha-NET, a few days before the first two cycles to track where the drug travels in the body using scans. After each dose, participants will stay in the hospital for a few nights and have weekly blood tests during each cycle. Participants will have physical exams, blood and urine tests, heart function tests, and imaging scans before and during the study. Researchers will monitor safety, drug effects, and tumor response through scans, lab tests, and questionnaires. Follow-up visits will continue for up to six years after the last treatment to check on long-term outcomes and overall health.

Researchers are investigating the timing of carbon nanoparticle injections in patients undergoing surgery for papillary thyroid cancer. The study aims to compare the benefits of preoperative versus intraoperative injection of carbon nanoparticles to improve the detection of parathyroid glands and lymph node clearance, while minimizing complications like hypoparathyroidism and nerve injury. This phase 3 trial involves over 400 patients and seeks to establish standardized guidelines for injection dose, timing, and method. Participants are divided into four groups based on whether they receive partial or total thyroidectomy and whether carbon nanoparticles are injected preoperatively or intraoperatively. The preoperative injection involves ultrasound-guided fine needle puncture 2 to 6 hours before surgery, delivering a total of 0.4 mL carbon nanoparticles at specific thyroid gland sites. The intraoperative injection is administered after thyroid exposure during surgery with the same total dose and injection technique to reduce leakage. Throughout the study, researchers will collect detailed data including patient demographics, tumor characteristics, biochemical markers, and surgical outcomes. They will monitor intraoperative conditions such as lymph node and parathyroid staining, nanocarbon leakage, operation duration, and bleeding. Postoperative assessments include pain duration, drainage, hospitalization length, calcium and hormone levels, nerve function, and complications like hematoma or fistula. Data will be collected for up to three years to evaluate the impact of injection timing on surgical success and patient quality of life.

Researchers are evaluating a new dual-targeting molecular probe called 68Ga-TATE-RGD for imaging tumors that express somatostatin receptor 2 (SSTR2) and integrin 23. This study focuses on patients with tumors such as small cell lung cancer, pulmonary carcinoid, medullary thyroid cancer, and neuroendocrine tumors (NETs) that show positive expression of these receptors. The goal is to improve tumor detection and explore potential therapeutic uses of this dual-target tracer compared to existing single-target tracers. Participants will receive intravenous injections of the imaging agents 68Ga-TATE-RGD and 18F-FDG at specified doses for PET/CT and SPECT/CT scans. About 30 patients with confirmed positive expression of SSTR2 and integrin 23 will undergo imaging to assess the tracer's ability to detect tumors. The study is conducted under an early phase 1 protocol with no masking or blinding. During the study, patients will undergo PET/CT and SPECT/CT imaging within a week using the tracers. Researchers will measure tumor detection rates and standardized uptake values (SUV) over an average follow-up of half a year. Assessments include imaging evaluations and monitoring for any medical conditions affecting compliance. The total duration of participation varies but includes imaging and follow-up to evaluate diagnostic performance and tracer kinetics.

Researchers are evaluating af-001, an alpha particle-emitting radiopharmaceutical, in patients with differentiated thyroid cancer (papillary carcinoma, follicular carcinoma) who have undergone total thyroidectomy. The study focuses on patients with radically unresectable, recurrent, or metastatic disease that is either resistant or intolerant to standard treatments, or who have not previously received radioactive iodine therapy. This Phase I trial aims to find safe dosage levels and assess tumor response. The trial has two parts: Part Ia involves escalating doses of a single intravenous af-001 administration to determine safety, tolerability, and the maximum tolerated dose (MTD). Part Ib is a randomized study where patients receive multiple doses at either the MTD or one dose level below it (MTD-1). Ten patients will be assigned to each of the two treatment arms using a stratified randomization based on metastasis sites. Participants will undergo monitoring for dose-limiting toxicities over 4 weeks in Part Ia and tumor size assessments via MRI or CT scans over 24 weeks in Part Ib. Eligibility requires stable health with an ECOG performance status of 0 to 2 and an expected survival of at least 6 months. Safety is closely observed, and the study runs from 2026 to 2028, led by Alpha Fusion Inc.

Researchers are evaluating whether the transoral endoscopic thyroidectomy vestibular approach (TOETVA) is a safe and effective alternative to traditional open thyroidectomy for patients with benign or suspicious malignant thyroid nodules. This prospective case control study involves 40 patients divided into two groups: one receiving TOETVA and the other undergoing conventional open surgery. The study aims to assess surgical outcomes, patient satisfaction, voice quality, and swallowing function. Participants will either have surgery using the TOETVA, which is a remote access procedure through the mouth, or the traditional open thyroidectomy through the neck. The study is non-randomized, assigning 20 patients to each group. Outcomes such as lower lip numbness, skin injury, operation time, blood loss, vocal cord paralysis, and hypoparathyroidism will be monitored. The study also evaluates patient satisfaction and quality of life related to voice and swallowing using specific questionnaires. After surgery, patients will be followed up with assessments on days 1, 14, and 6 months post-operation to measure satisfaction, pain, voice, and swallowing quality of life. Surgical complications will be recorded at 2 weeks and 6 months. Secondary measures include hospital stay duration, operative time, blood loss, and conversion rates to open surgery. The total study duration spans from surgery through 6 months of follow-up.

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.