Neoplasms

Gland and Hormone Related Diseases

All Conditions

Thyroid Neoplasms

Thyroid Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Anti-Infective Agents

Trametinib

Dabrafenib

Iodine

Cadexomer iodine

Protein Kinase Inhibitors

Enzyme Inhibitors

2mg daily for a maximum of 6 weeks of treatment

131I

0.9mg on two consecutive days after 35 days of treatment

rhTSH

This is a multicentric prospective non-randomized phase II trial, with two independent arms: one for patients with RAS mutation and one for patients with BRAFV600E mutation.

This is a multicentric prospective non-randomized phase II trial, with two independent arms: one for patients with RAS mutation and one for patients with BRAFV600E mutation

Efficacy of MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer

Efficacy of a Selective MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors Associated With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer With RAS or BRAFV600E Mutation

Propotion of patients with a best overall response of Complete Response (CR) or a Partial Response (PR)

Gustave Roussy, Cancer Campus, Grand Paris

Hormones

Hormone Antagonists

rhTSH: rhTSH(0.9 mg) was administered intramuscularly (IM) once daily (qd) for 2 days. Twenty-four hours following the second dose of rhTSH.Oral radioiodine was given 24 hours after the second injection of rhTSH, and scanning was done 48 hours after the radioiodine administration.

Thyroid hormone withdrawal: Patients stop taking thyroid hormone for 14 days, and then monitor the level of thyroid stimulating hormone every week. When TSH\>30mU/L, an ablative activity of 131I was administered.and scanning was done 48 hours after the radioiodine administration.

Scanning was done 48 hours after the radioiodine administration. Each patient was scanned first following rhTSH and then scanned after thyroid hormone withdrawal.

Yansong Lin, PhD

This is A non-blinded trial. Oral radioiodine was given 24 hours after the second injection of rhTSH, and scanning was done 48 hours after the radioiodine administration. Each patient was scanned first following rhTSH and then scanned after thyroid hormone withdrawal.

Comparison of the Efficacy and Safety of rhTSH as An Adjunctive Diagnostic Tool in Differentiated Thyroid Cancer Patients Who Had Been Thyroidectomized Vs. Patients Who After Thyroid Hormone Withdrawal

An Open, Single-arm, Self-controlled, Multi-center Phase 3 Study to Compare the Efficacy and Safety of rhTSH as An Adjunctive Diagnostic Tool in Differentiated Thyroid Cancer Patients Who Had Been Thyroidectomized Vs. Patients Who After Thyroid Hormone Withdrawal

scan findings in agreement in a given patient using each preparation method

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Rare Diseases

Carcinoma

Thyroid Cancer, Papillary

Adenocarcinoma, Follicular

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma, Papillary

Papillary Thyroid Carcinoma

Thyroid Cancer, Follicular

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

* Participants will be treated with Selpercatinib for 4 weeks.
* In the fourth week of treatment, participants will receive a therapeutic dose of I-131.

  * Those participants in whom radioiodine uptake has been restored may be offered a second 4-week course of selpercatinib plus I-131 treatment

Selpercatinib Oral, twice daily during initial treatment period (28 Days). A second course of selpercatinib if the participant is demonstrating clinical benefit to the initial course selpercatinib and deemed clinically appropriate by the treating investigator

Selpercatinib

I-131, oral, is a standard treatment for all types of follicular-derived thyroid cancers, except anaplastic thyroid cancer

Sodium Iodine I-131

RhTSH injection, dosage per protocol, timing per protocol during the initial treatment period per standard of care.

Participants may receive a second course of rhTSH if the participant is demonstrating clinical benefit to the initial course rhTSH and deemed clinically appropriate by the treating investigator.

Lori J. Wirth, MD

Lori J Wirth, MD

This research is being done to determine the efficacy of selpercatinib to restore radioactive iodine (I-131) uptake and allow for I-131 treatment in people with RET fusion-positive radioiodine-refractory thyroid cancer.

This research study involves the study drug selpercatinib in combination with standard of care treatments, I-131 and thyrotropin alfa (rhTSH).

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

* This research study involves the study drug selpercatinib in combination with standard of care treatments, I-131 and thyrotropin alfa (rhTSH). Participants receive study treatment for as long as the disease does not worsen (disease progression) for approximately 1 month for up to two courses of treatment, if participants do not experience any unacceptable side effects, and/or until withdrawal of consent.
* Participants will be followed for 2 years from the date of study registration.
* It is expected that about 30 people will take part in this research study/
* This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.

  * The U.S. FDA has approved selpercatinib, I-131 and rhTSH as a treatment option for this disease.
  * The combination therapy is investigational as it has not been approved to treat this disease.
* Selpercatinib, I-131 and rhTSH are standard of care treatment options for thyroid cancer. Selpercatinib is a small molecule designed to block the active RET signaling.

Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC

Restoration of Radioiodine Uptake With Selpercatinib in RET Fusion-Positive Radioiodine-Refractory Thyroid Cancer: A Phase 2 Study Performed in Collaboration With the International Thyroid Oncology Group (ITOG)

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

RECIST v1.1 or Nies criteria in adolescents without RECIST-measurable disease The primary endpoint is best overall response (ORR) (CR and PR) at 6 months. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters

The safety profile of selpercatinib plus I-131 treatment in this patient population, will be evaluated by assessing by the incidence of treatment-related adverse events per Common Terminology Criteria for Adverse Events (CTCAE) v5.0

The estimated rate of restoration of I-131 uptake in patients with RAI-refractory RET fusion-positive thyroid cancer treated with selpercatinib will be estimated by determining the rate of positive whole body scans performed after I-131 administration.

The estimated best thyroglobulin biochemical response rates will be determined by comparing serial serum thyroglobulin levels taken every 3 months following treatment to that of the pretreatment baseline level in participants with measurable serum thyroglobulin. Best biochemical response is defined as follows: equals normalization of thyroglobulin level; partial response equals

≥50% decrease from baseline thyroglobulin; stable disease equals \<50% decrease or increase from baseline; and biochemical progression equals ≥50% increase from baseline (each maintained for at least 4 weeks).

Kaplan-Meier Method Time to subsequent systemic treatment in patients with RET fusion-positive RAIrefractory thyroid cancer will also be estimated.

The structural, biochemical, and overall response rate perl \[19\] for adolescent patients who enroll without measurable disease will be reported descriptively for adolescents who enroll without RECIST measurable disease.

Eli Lilly and Company

Massachusetts General Hospital

Principal Investigator

Behaviors and Mental Disorders

Quality of Life

To receive the placebo treatment in connection with the primary RI therapy and the T3 tablets and rh-TSH injections prior to second RI uptake measurement

To continue with L-T3 and to receive rh-TSH stimulation with 0,9 mg Thyrogen® (Genzyme) x 2 days minus 1 and 2 prior to RI therapy, and following this to have placebo tablets and placebo injections with isotone NaCl prior to the RI uptake measurement 4-6 months later

The patients will be randomised to either T3 (Liothyronine) pause related to the first radioiodine treatment and Thyrogen injection with continuing Liothyronine treatment related to the second treatment/uptake - or Thyrogen related to the first treatment and T3 pause related to the second treatment /uptake.

Birte Nygaard, Md, PhD

To evaluate quality of life in patients after 10 days pause of thyroid medication (Liothyronine) compared to treatment with recombinant TSH (Thyrogen) before radioiodine uptake and treatment in a double-blinded, randomised cross-over design.

Patients with a thyroid follicular or papillary cancer referred to radioiodine treatment in oncological department . The patients after thyroidectomy will be treated with Liothyronine and this treatment will be paused 10 days before radioiodine. As a routine these patients will be re-evaluated with iodine uptake 4 months later.

The patients will be randomised to either T3 pause related to the first radioiodine treatment and Thyrogen injection (recombinant TSH) related to the second treatment/uptake - or Thyrogen related to the first treatment and T3 pause related to the second treatment /uptake.

All medication given in the 10 days period right before radioiodine treatment/uptake will be delivered to the patients and marked with a protocol number. In the period with T3 pause the patients will be given placebo tablets and an injection of saline (instead of Thyrogen) before treatment/uptake at the similar time as given the Thyrogen injection. A nurse otherwise not involved in the study will give the injection.

Patients will be evaluated by VAS, SF-36, and Eortc QLC30 (version 2.0) before radioiodine treatment and 3 weeks after treatment.

Quality of Life, Recombinant TSH (Thyrogen) and Thyroid Cancer

Is it Possible to Increase Quality of Life, Using Recombinant TSH Instead of Withdrawal of Thyroid Hormone Treatment, Before Iodine Uptake in Patients With Thyroid Cancer?

Odense University Hospital

Copenhagen University Hospital at Herlev

Period 1 GX-30 0.9mg x 2 (Day 1 and Day 2), IM injection. Period 2 THYROGEN® 0.9mg x 2 (Day 1 and Day 2), IM injection

Period 1 THYROGEN® 0.9mg x 2 (Day 1 and Day 2), IM injection. Period 2 GX-30 0.9mg x 2 (Day 1 and Day 2), IM injection

Part B - Sequence A. GX-30 0.9mg will be administered at Day 1 and Day 2 in Period 1. After wash-out period of 2 to 3 weeks, THYROGEN® 0.9mg will be administered in Period 2.

Period 1 GX-30, Period 2 THYROGEN®

Part B - Sequence B. THYROGEN® 0.9mg will be administered at Day 1 and Day 2 in Period 1. After wash-out period of 2 to 3 weeks, GX-30 0.9mg will be administered in Period 2.

Period 1 THYROGEN®, Period 2 GX-30

Mu Il Kang, M.D., Ph. D.

This study is designed as a combination of phase 1 (Part A) and phase 2 (Part B). The purpose of Part A was to determine the safety, tolerability, and pharmacokinetics in patients with total thyroidectomy or near total thyroidectomy of GX-30 and it has been completed. The Part B is currently recruiting and will investigate the efficacy and safety of GX-30 compared with THYROGEN®.

Recombinant human TSH was developed to provide TSH stimulation without withdrawal of thyroid hormone. Radioiodine ablation and diagnosis with rhTSH became the standard of care treatment for patients with differentiated thyroid cancer. Stably supplying rhTSH has been the unmet need for management and follow-up procedure for thyroid remnant. GX-30 is an investigational product, developed to provide inexpensive rhTSH to patients in order to ensure stable supply of rhTSH.

The Part A (Phase 1) of study has been completed in which 3 single or multiple sequentially assenting doses of GX-30 were investigated. The Part B (Phase 2) is recruiting in current in which each study participant will receive the same multiple doses of GX-30 and THYROGEN® but at different period.

At Part B, Both independent central efficacy assessors and participants will be masked. Investigators will be unmasked. (The Part A was open-label.)

Pregnant or lactating women will be excluded. Women of childbearing potential who agreed to use a medically appropriate conceptional method till 6 months after study completion may be enrolled.

Tolerability, Safety and Pharmacokinetics Study of GX-30 in Total Thyroidectomy or Near Total Thyroidectomy Patients

A Prospective, Open-label, Dose Escalation,(Phase 1); Prospective, Randomized, Evaluator Blinded, Active-controlled, 2-sequence, 2-period, 2-treatment, Crossover(Phase 2); Phase 1/2 Clinical Trial to Evaluate the Tolerability, Pharmacokinetics, Safety and Efficacy of GX-30 Administered Intramuscularly in Patients Underwent Total Thyroidectomy or Near Total Thyroidectomy

I-123 Whole body scan image classification

TSH concentration for Pharmacokinetics assessment

Thyroglobulin concentration for secondary efficacy assessment

Thyroid hormones concentration for pharmacodynamic assessment

Symyoo

Genexine, Inc.

All patients will receive one extra imaging scan with I-123 in addition to their routine care as described above. This research portion of their care will be similar to the scan that they undergo for the I-123 planning scan that is already a part of their routine care. The research study, which will be performed in the middle of the patient's normal standard of care treatment, will take 4 days.

On days 1 and 2, all patients will receive a intramuscular injection of rhTSH (Thyrogen).

On day 3, all patients will be given 3 mCi of I-123 in the form of a pill to take by mouth.

On day 4, all patients will receive a I-123 Whole Body Imaging Scan and a thyroid camera scan of the neck and thigh.

Intramuscular injections of rhTSH (Thyrogen) will be given on days 1 and 2.

Jennifer Kwak, MD

The purpose of the study is to find out if the small dose of radioiodine, that is used for the dosimetry study on patients with differentiated thyroid cancer, may stun the cancer cells and make the thyroid cancer treatment less effective.

This study plans to learn more about a medical problem called thyroid stunning. Thyroid stunning is a temporary decrease in the function of thyroid cells after small doses of radioiodine, a radioactive drug that is commonly used to treat thyroid cancer. Thyroid stunning can be an important medical problem in patients who have thyroid cancer that has spread beyond the thyroid gland (metastases). In patients with thyroid cancer metastases, some researchers believe it is good to give the maximum safe dose of radioiodine in order to have the greatest chance of destroying the cancer. The maximum safe dose is the highest dose of radioiodine that a patient can safely receive, and this dose is unique to each person. This special personalized dose is determined by first doing a dosimetry study. Dosimetry study is a planning study that calculates the safest dose that the patient can receive. Currently, it is not known whether the small dose of radioiodine that is used for the dosimetry study may stun the cancer cells and make the thyroid cancer treatment less effective.

There are two important types of radioiodine. I-123 is a form of radioiodine that is used to take pictures of the thyroid gland. I-131 is a form of radioiodine that is used to treat thyroid cancer. It is hoped that this study will produce important information that may be the first step in resolving the thyroid stunning question. Investigators will use I-123, a form of iodine that is currently not known to cause thyroid stunning, before thyroid cancer treatment with I-131. Investigators will try to prove that I-123 does not cause thyroid stunning and does not make the thyroid cancer treatment less effective.

Patients are being asked to be in this research study because they have differentiated thyroid cancer, and they have no evidence of thyroid cancer that has spread to the other parts of their body. As a result, those patients thyroid cancer treatment with radioiodine will be a smaller amount than what is needed to treat patients with thyroid cancer that has spread to other parts of the body. Thyroid stunning is not a medical problem for patients like these. However, by participating in this study, the information investigators gather from those patients treatment of thyroid cancer may help those patients with thyroid cancer metastases.

Evaluation of Thyroid Stunning From a Diagnostic Dose of I-123

Greater than a 20% decrease from the first to second study will indicate evidence of stunning.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy of MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer	NCT03244956	Metastatic Radi...	Trametinib Dabrafenib 131I rhTSH	18 Years -	Gustave Roussy, Cancer Campus, Grand Paris
Comparison of the Efficacy and Safety of rhTSH as An Adjunctive Diagnostic Tool in Differentiated Thyroid Cancer Patients Who Had Been Thyroidectomized Vs. Patients Who After Thyroid Hormone Withdrawal	NCT04971473	Differentiated ...	rhTSH	18 Years - 75 Years	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC	NCT05668962	Thyroid Cancer Thyroid Carcino... Metastatic Thyr... Follicular Thyr... Unresectable Th... Papillary Thyro...	Selpercatinib Sodium Iodine I... rhTSH	12 Years -	Massachusetts General Hospital
Quality of Life, Recombinant TSH (Thyrogen) and Thyroid Cancer	NCT00604318	Thyroid Cancer	rhTSH	18 Years - 75 Years	Copenhagen University Hospital at Herlev
Tolerability, Safety and Pharmacokinetics Study of GX-30 in Total Thyroidectomy or Near Total Thyroidectomy Patients	NCT03276988	Total Thyroidec... Near-total Thyr...	Period 1 GX-30,... Period 1 THYROG...	19 Years -	Genexine, Inc.
Evaluation of Thyroid Stunning From a Diagnostic Dose of I-123	NCT02278198	Differentiated ...	rhTSH	21 Years -	University of Colorado, Denver

Spots Global Cancer Trial Database for rhtsh

Every month we try and update this database with for rhtsh cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rhtsh

Every month we try and update this database with for rhtsh cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rhtsh cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.