Neoplasms

All Conditions

Gland and Hormone Related Diseases

Carcinoma

Thyroid Neoplasms

Thyroid Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Iodine

Cadexomer iodine

Parathyroid Hormone

Anti-Infective Agents, Local

Trace Elements

131 I-iodine (131-I), 124 I-iodine (124-I)

Those who have demonstrated metastases which concentrate radioiodine will undergo routine testing to determine the MTA for blood and lung tissue. This will be performed with 124-I instead of 131-I. If the diagnostic scans (done with 123-I) show that the metastatic lesions concentrate radioiodine, the patient will be treated with 131-I based on standard of care discussions at a tumor board meeting. One week following the 131-I therapy, a whole body scan will be obtained and compared with the 124-I diagnostic scan. One year later, another extent of disease workup will be performed which will include 124-I dosimetry and scanning.

Ravinder Grewal, MD

One of the most effective treatments for metastases from thyroid cancer is a form of radioactive iodine known as 131-I. For more than 50 years, 131-I has been used to find and destroy thyroid cancer cells that have spread to other parts of the body. In many cases this treatment destroys the metastatic cells. However, in some patients it does not appear to work completely. This study is designed to use a slightly different form of radioactive iodine (called 124-I) which can precisely predict the amount of radiation that each metastatic lesion will receive.

124-I was developed at Memorial Sloan-Kettering in the 1950s and has been used here and at many other medical centers around the world for diagnostic studies. It has been found to be very safe and effective at finding metastatic lesions. The high resolution of newer PET scanners now allows us to carefully determine how much radiation each metastatic lesion will receive. If 124-I can accurately predict which patients will not respond to 131-I treatments we can then avoid exposing those patients to unnecessary radiation. For the rest of the patients we can custom tailor the 131-I dose to destroy the metastatic lesions.

Lesion Dosimetry With 124-Iodine in Metastatic Thyroid Carcinoma

Gustave Roussy, Cancer Campus, Grand Paris

Memorial Sloan Kettering Cancer Center

Symptoms and General Pathology

Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Hyperthyroidism

Neoplastic Processes

Parathyroid Diseases

Bone Density Conservation Agents

Vasoconstrictor Agents

Vitamins

Cinacalcet

Vitamin D

Cholecalciferol

Calcium

Alfacalcidol

Hydroxycholecalciferols

Calcium, Dietary

Calcitriol

1 alpha-hydroxyergocalciferol

Hormones

Hormone Antagonists

Vitamin D3

Calciferol

Traditional vitamin D therapy (eg, calcitriol, paricalcitol, alfacalcidol, doxercalciferol), to manage secondary hyperparathyroidism (SHPT) in this study will be administered according to strategies that have been used in clinical practice and that conform to current therapeutic recommendations and available clinical practice guidelines and product labeling.

Traditional Vitamin D Therapy

Subjects randomized to treatment with cinacalcet will receive an initial oral dose of 30 mg once daily. Doses will be titrated incrementally to 60, 90,120, and 180 mg per day based upon periodic measurements of serum calcium and plasma PTH levels. Cinacalcet is formulated as light green tablets in 30, 60, and 90 mg free-based equivalents. Tablets will be 30, 60, and 90 mg, graduated in size, smallest to largest. Combinations of these 3 fixed dosage formulations will be used to achieve the 120 and 180 mg daily doses.

The purpose of this study is to determine the efficacy of treatment with cinacalcet to manage plasma parathyroid levels as to compared traditional vitamin D therapy, whether given orally or intravenously, among hemodialysis subjects with secondary hyperparathyroidism when the doses are adjusted appropriately to maintain serum calcium and phosphorous levels with currently recommended ranges.

Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis

A Multicenter, Randomized, Open Label Study to Compare the Efficacy of Cinacalcet Versus Traditional Vitamin D Therapy for Management of Secondary Hyperparathyroidism Among Subjects Undergoing Hemodialysis

Mean PTH during EAP is defined as the mean of values at study weeks 40, 44, 48 and 52

Number of participants achieving a \>=30% Reduction From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)

Number of participants achieving Plasma PTH \< 300 pg/mL During Efficacy Assessment Phase (EAP)

Amgen

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.

Vitamin D sterol, intravenous (IV) or oral

Traditional Vitamin D

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

More than one race

Unknown or Not Reported

Race/Ethnicity, Customized

Study Director

Null hypothesis: no difference in % change from baseline in PTH comparing the two treatment arms.

All subjects randomized by treatment arm.

Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)

Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP)

Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)

Overall Study

Rare Diseases

Hypoparathyroidism

Neovascularization, Pathologic

Metaplasia

Patients who undergo thyroid surgery and receive indocyanine green angiography

Indocyanine green is used to perform intraoperative angiography.

Indocyanine green

The device is used to perform intraoperative angiography.

SPY Portable Handheld Imaging (SPY-PHI)

Riccardo Rosati, Prof.

Prospective, observational, single-center study about the use of indocyanine green angiography during total thyroidectomy.

The main objective of the study is to identify a quantitative score of parathyroid vascularization as an outcome of angiography that correlates with the absence of postoperative hypoparathyroidism.

It is planned to enroll 66 patients.

Postoperative hypoparathyroidism and subsequent hypocalcemia are the most frequent complications after thyroid surgery. The incidence ranges from 19-38%, depending on the definition of hypoparathyroidism and hypocalcemia.

Although the cause of postoperative hypoparathyroidism is multifactorial, one of the most important factors is vascularization of parathyroid glands left in situ that is insufficient or impaired by surgical manipulation. Therefore, one of the goals of thyroid surgery is not only to recognize the parathyroid glands during dissection but also to respect their vascularization in order to preserve well perfused and viable glands.

The general objective of this study is to quantitatively assess the vascularization of the parathyroids following total thyroid removal.

In particular, the investigators intend to obtain data regarding parathyroid vascularization during total thyroidectomy with indocyanine green angiography. During standard surgery, angiography will be performed using a special camera after having administered intravenously indocyanine green. This technique is used to objectively assess the degree of fluorescence of the parathyroid glands.

Parathyroid Vascularization During Total Thyroidectomy Using Indocyanine Green Angiography

Analysis of Parathyroid Vascularization During Total Thyroidectomy Using Quantitative Real-time Indocyanine Green Angiography

A quantitative score of parathyroid vascularization as an outcome of indocyanine green angiography during thyroidectomy that correlates with the absence of postoperative hypoparathyroidism.

The score will be reported as a percentage (range 0% - 200%) where the higher score means the better outcome.

IRCCS San Raffaele

Principal Investigator

Identify the parathyroid glands through the experience of surgeons and assistance of instrument.

Identify the parathyroid glands only through the experience of surgeons.

The enrolled patients are grouped according to whether or not to use the intraoperative parathyroid auxiliary recognition system.

Intraoperative parathyroid gland auxiliary recognition system

Yu Wang, Doctor

This intraoperative parathyroid gland auxiliary recognition system uses the principle of parathyroid gland autofluorescence to assist surgeons in accurately identifying and protecting parathyroid glands during surgery, reducing the possibility of postoperative hypoparathyroidism. This study will explore the protective effect of the parathyroid gland auxiliary recognition instrument on parathyroid function during thyroid malignant tumor surgery through reasonable grouping.

Protective Effect of Intraoperative Parathyroid Gland Auxiliary Recognition System in Thyroid Malignant Tumor Operation

Patients' serum Calcium level at 24 hours after surgery.

Patients' serum Calcium level at 1 month after surgery.

Patients' serum PTH level at 24 hours after surgery.

Patients' serum PTH level at 1 month after surgery.

Fudan University

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Recurrence

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Laryngeal Diseases

Antineoplastic Agents

Hematinics

Carboplatin

Pemetrexed

Cetuximab

Cisplatin

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Antineoplastic Agents, Immunological

Folinic Acid

Folate

Vitamin B9

Cycle 1:

Week 1 - Cetuximab 400 milligrams/square meter (mg/m²) on Day 1; Pemetrexed 500 mg/m² on Day 1; Carboplatin area under curve (AUC) 5 on Day 1 or Cisplatin 75 mg/m² on Day 1

Week 2 - Cetuximab 250 mg/m² on Day 1

Week 3 - Cetuximab 250 mg/m² on Day 1

Cycle 2-6:

Week 1 - Cetuximab 250 mg/m² on Day 1; Pemetrexed 500 mg/m² on Day 1; Carboplatin AUC 5 on Day 1 or Cisplatin 75 mg/m² on Day 1

Week 2 - Cetuximab 250 mg/m² on Day 1

Week 3 - Cetuximab 250 mg/m² on Day 1

Following Cycle 6, Cetuximab Monotherapy: 250 mg/m² intravenously weekly on Day 1

Administered intravenously, for maximum of 6 cycles.

Administered intravenously in combination therapy, for a maximum of 6 cycles.

After the completion of 6 cycles, participants who have not experienced disease progression will continue on cetuximab monotherapy until disease progression.

Administered intravenously, for a maximum of 6 cycles

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

The purpose of this study is to look for an improvement in progression free survival with the combination of pemetrexed, carboplatin (or cisplatin) and cetuximab in participants with recurrent or metastatic squamous cell carcinoma of the head and neck.

A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer

Phase 2 Study of Pemetrexed in Combination With Carboplatin or Cisplatin and Cetuximab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Presented are the number of participants who died due to adverse events (AEs) while on treatment and participants who died due to progressive disease (PD) during the 30-day post-treatment discontinuation FU.

PFS was defined as the duration from the date of enrollment to the first date of documented objective progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who were not known to have died or to have had objective PD at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.

OS is defined as the duration from the date of enrollment to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the date of last contact prior to that cut-off date.

PR or CR is classified by the investigators according to RECIST criteria version 1.0. PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions; CR is the disappearance of all target and non-target lesions. Percentage of participants having a PR or CR is calculated as a total number of participants with PR or CR from enrollment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.

EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. A regression equation defines a utility value for these health states to generate an index score. The possible values for index score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. The EQ-5D Visual Analog Scale (VAS) is used to record a participant's rating for his/her current health-related quality of life state on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).

PSS-HNC is a clinician-rated instrument designed to measure speaking and eating disabilities of participants with head and neck cancer and consists of 3 subscales: normalcy of diet (NOD) subscale measures the ability of the participants to eat a normal diet, subscale ranges from 0 (non-oral feeding) to 100 (unrestricted diet); understandability of speech (UOS) subscale measures the degree a clinician is able to understand the participant's speech, subscale ranges from 0 (never understandable) to 100 (always understandable); eating in public (EIP) subscale, rating based on the participant's response to the questions of whom he/she eats with and in what setting, subscale ranges from 0 (always eats alone) to 100 (no restriction of place, food, or companion). Change from baseline: negative value represents a decrease in function and a positive value represents an increase in function.

Eli Lilly and Company

Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.

Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.

Carboplatin AUC 5 administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.

Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.

Cetuximab + Pemetrexed + Carboplatin

Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.

Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.

Cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.

Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.

Cetuximab + Pemetrexed + Cisplatin

Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly.

Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.

Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.

Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.

Cetuximab + Pemetrexed + Carboplatin/Cisplatin

Race (NIH/OMB)

United States

Region of Enrollment

Index Score (n=47)

Visual Analog Scale (VAS) Score (n=47)

Participants assessed health-related QoL in 5 D (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) as no problems/some or moderate problems/extreme problems. A regression equation defines a utility value for these health states to generate an index score from -0.594 (severe problems in all 5 D) to 1 (no problem in all 5 D) where 1=best possible health state. EQ-5D VAS rates participant's current health-related QoL on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).

European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)

NOD (n=57)

UOS (n=57)

EIP (n=57)

Clinician measured speaking and eating disabilities of HNC participants that consists 3 subscales: normalcy of diet (NOD) measures ability of eating a normal diet, scale from 0 (non-oral feeding) to 100 (unrestricted diet); understandability of speech (UOS) measures the degree a clinician was able to understand participant's speech, scale from 0 (never understandable) to 100 (always understandable); eating in public (EIP) is based on clinician's question to the participant, scale from 0 (always eats alone) to 100 (no restriction of place, food, or companion).

Performance Status Scale for Head and Neck Cancer (PSS-HNC)

All enrolled participants who received at least 1 dose of study drug.

Efficacy populations excluded data from a noncompliant site (11 participants).

Chief Medical Officer

Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.

Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.

Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.

Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.

All treated participants excluding those from a noncompliant study site. The number of participants censored was 9.

Progression-Free Survival (PFS)

All treated participants excluding those from a noncompliant study site. The number of participants censored was 22.

Overall Survival (OS)

All treated participants excluding those from a noncompliant study site.

Percentage of Participants Having a Confirmed Partial Response (PR) or Complete Response (CR)

Change in Index Score at Cycle 2 (n=43)

Change in Index Score at Cycle 4 (n=29)

Change in Index Score at Cycle 6 (n=24)

Change in Index Score at monotherapy Cycle2 (n=14)

Change in Index Score at monotherapy Cycle 4 (n=7)

Change in VAS Score at Cycle 2 (n=41)

Change in VAS Score at Cycle 4 (n=28)

Change in VAS Score at Cycle 6 (n=21)

Change in VAS Score at monotherapy Cycle 2 (n=14)

Change in VAS Score at monotherapy Cycle 4 (n=7)

All treated participants who completed the EQ-5D-3L and VAS at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.

Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)

Change in NOD at Cycle 2 (n=52)

Change in UOS at Cycle 2 (n=52)

change in EIP at Cycle 2 (n=52)

Change in NOD at Cycle 4 (n=34)

Change in UOS at Cycle 4 (n=35)

Change in EIP at Cycle 4 (n=34)

Change in NOD at Cycle 6 (n=28)

Change in UOS at Cycle 6 (n=28)

Change in EIP at Cycle 6 (n=28)

Change in NOD at monotherapy Cycle 2 (n=16)

Change in UOS at monotherapy Cycle 2 (n=16)

Change in EIP at monotherapy Cycle 2 (n=17)

Change in NOD at monotherapy Cycle 4 (n=9)

Change in UOS at monotherapy Cycle 4 (n=9)

Change in EIP at monotherapy Cycle 4 (n=9)

All treated participants who had PSS-HNC assessments at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.

Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)

Due to AE while on treatment

All enrolled participants who received at least 1 dose of any study drug.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lesion Dosimetry With 124-Iodine in Metastatic Thyroid Carcinoma	NCT00673010	Thyroid Cancer	131 I-iodine (1...	18 Years -	Memorial Sloan Kettering Cancer Center
Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis	NCT01181531	Hyperparathyroi...	Traditional Vit... Cinacalcet	18 Years -	Amgen
Parathyroid Vascularization During Total Thyroidectomy Using Indocyanine Green Angiography	NCT05328076	Thyroid Thyroid Cancer Hypoparathyroid... Vascularization	Indocyanine gre... SPY Portable Ha...	18 Years -	IRCCS San Raffaele
Protective Effect of Intraoperative Parathyroid Gland Auxiliary Recognition System in Thyroid Malignant Tumor Operation	NCT04560426	Parathyroid Intraoperative ... Thyroid Cancer	Intraoperative ...	20 Years - 50 Years	Fudan University
Protective Effect of Intraoperative Parathyroid Gland Auxiliary Recognition System in Thyroid Malignant Tumor Operation	NCT04560426	Parathyroid Intraoperative ... Thyroid Cancer	Intraoperative ...	20 Years - 50 Years	Fudan University
A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer	NCT01087970	Head and Neck N...	Pemetrexed Cetuximab Carboplatin Cisplatin	18 Years -	Eli Lilly and Company
Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism	NCT00754442	Secondary Hyper...	Teriparatide	40 Years - 59 Years	University of Maryland, Baltimore
Protective Effect of Intraoperative Parathyroid Gland Auxiliary Recognition System in Thyroid Malignant Tumor Operation	NCT04560426	Parathyroid Intraoperative ... Thyroid Cancer	Intraoperative ...	20 Years - 50 Years	Fudan University
Evaluation of MRI and SPECT Fusion Software to Localize Parathyroid Adenomas	NCT00639405	Parathyroid Neo... Parathyroid Dis...		18 Years - 80 Years	State University of New York - Upstate Medical University
Registry of Endocrine Tumors (Thyroid, Parathyroid, Adrenal, Endocrine Pancreas, Endocrine Digestive Tube)	NCT03410394	Endocrine Tumor		-	Central Hospital, Nancy, France

Spots Global Cancer Trial Database for parathyroid

Every month we try and update this database with for parathyroid 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 parathyroid

Every month we try and update this database with for parathyroid 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 parathyroid 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.