Neoplasms

Gland and Hormone Related Diseases

All Conditions

Thyroid Neoplasms

Thyroid Diseases

Thyroid Nodule

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Potentially cancerous thyroid nodules were assessed by elastrography, then a fine needle biopsy specimen or the surgically-excised nodule was assessed pathologically to determine cancer status.

Siemens Acuson S3000 ultrasound system

Aya Kamaya

This clinical trial studies how well ultrasound elastography works in assessing the cancer status of potentially malignant thyroid nodules.

PRIMARY OBJECTIVES:

Determine the utility of ultrasound elastography in evaluation of thyroid nodules being evaluated for the presence of cancer.

Elastography measures the passages of ultrasound shear waves through tissue to gauge the stiffness and compressibility of the tissue, collectively "tissue stiffness," and may be a better way to image thyroid nodules. Tissue stiffness is a physiological parameter that is being evaluated for differences between non-cancerous (benign) and cancerous thyroid nodules.

Participants will undergo elastography over the 10 minutes prior to either fine needle aspiration of a biopsy specimen or surgical resection of the thyroid nodule. Tissue specimens from the biopsy specimen or surgical resection will be assessed pathologically to determine actual cancer status.

Ultrasound Elastography in Imaging Patients With Thyroid Nodules

Elastography in Thyroid Nodule Evaluation

Potentially cancerous thyroid nodules will be assessed elastographically, and cancer status will be determined from a fine needle aspiration biopsy results or the surgically excised nodule. The outcome will be reported as median tissue stiffness with standard deviation for nodules that were determined non-cancerous (benign), cancerous, or indeterminate.

Stanford University

Professor of Radiology

Potentially cancerous thyroid nodules were assessed by elastrography, then a fine needle biopsy specimen or the surgically-excised nodule was assessed pathologically to determine cancer status.

Siemens Acuson S3000 ultrasound system: Shear Wave Elastography

Tissue Stiffness by Elastography

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Aya Kamaya, Professor of Radiology

Pathologically Noncancerous Thyroid Nodules

Pathologically Cancerous Thyroid Nodules

Pathologically Indeterminate Thyroid Nodules

An individual participant could contribute multiple nodules.

Stiffness of Thyroid Nodules as Measured by Elastography

Overall Study

Carcinoma

Central Nervous System Depressants

All Drugs and Chemicals

Micronutrients

Anti-Infective Agents

Anesthetics

Iodine

Cadexomer iodine

Patients undergo collection of blood samples on the day of surgery following anesthesia but prior to incision and at the first routine blood test following surgery. Patients who undergo remnant ablation after total thyroidectomy with radioactive iodine have an additional blood sample collected. Patients also undergo collection of tissue samples following surgical resection of thyroid nodule or thyroid cancer. Patients' medical records are also reviewed.

Undergo collection of blood and tissue samples

Biospecimen Collection

Electronic Health Record Review

James Wu

This study is being done to help researchers learn more about and successfully diagnose cancer using blood samples and tissue samples from surgeries in patients with suspicious thyroid nodules or thyroid cancer. Diagnosing cancer in this way, as opposed to biopsies, may be less invasive to the patient. Analyzing blood and tissues samples may also help researchers to differentiate non-cancerous tumors from thyroid cancer and detect high-risk mutations to guide treatment.

PRIMARY OBJECTIVE:

I. Sensitivity and specificity of molecular profile of thyroid derived extracellular vesicles (EVs) as predictor of thyroid cancer.

SECONDARY OBJECTIVES:

I. Quantity of thyroid derived EVs captured in various stages of thyroid cancer.

II. Whether quantity of EVs decreases in proportion to response to therapy in thyroid cancer patients.

III. Optimal ribonucleic acid (RNA)/deoxyribonucleic acid (DNA) panel in thyroid tumor derived EVs to diagnose thyroid cancer.

OUTLINE:

Patients undergo collection of blood samples on the day of surgery following anesthesia but prior to incision and approximately 4-6 weeks after surgery. Patients who undergo remnant ablation after total thyroidectomy with radioactive iodine have an additional blood sample collected. Patients also undergo collection of tissue samples following surgical resection of the thyroid. Patients' medical records are also reviewed.

Development of Liquid Biopsy Technologies for Noninvasive Cancer Diagnostics in Patients With Suspicious Thyroid Nodules or Thyroid Cancer

Isolation and Characterization of Extracellular Vesicles in Patients With Thyroid Nodules and Thyroid Cancer

Jonsson Comprehensive Cancer Center

Symptoms and General Pathology

Rare Diseases

Recurrence

Thyroid Cancer, Papillary

Carcinoma, Papillary

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Adenocarcinoma

Adenocarcinoma, Papillary

Papillary Thyroid Carcinoma

Patients undergo ultrasound guided RFA over 1-2 hours.

Quality-of-Life Assessment

Radiofrequency Ablation

Kim Learned, MD

Kim O. Learned, MD

Kim O Learned

This phase IV trial studies the effect of radiofrequency ablation in treating patients with benign or low risk thyroid nodule. Radiofrequency ablation uses a needle to deliver a high-frequency electric current to kill tumor cells by heating them. The goal of this research study is to learn if ultrasound guided radiofrequency ablation can provide the same treatment result as standard surgical removal of the thyroid nodule, small primary thyroid, or thyroid cancers that have come back. Researchers also want to learn if the procedure can be less invasive and perhaps provide a better recovery response than surgery.

PRIMARY OBJECTIVE:

I. Evaluate the longitudinal thyroid nodule volume changes induced by radiofrequency ablation (RFA) during post procedure follow-up.

SECONDARY OBJECTIVES:

I. Evaluate treatment response to compressive and/or cosmetic symptoms that affect patient's quality of life.

II. Evaluate the sonographic features of the nodule induced by RFA.

III. Compare cost of ultrasound guided RFA to gold standard surgical thyroidectomy.

OUTLINE:

Patients undergo ultrasound guided RFA over 1-2 hours.

After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months.

Radiofrequency Ablation for the Treatment of Benign or Low Risk Thyroid Nodule

Radiofrequency Ablation Use in Thyroid Nodule

The change from baseline to follow-up will be evaluated using Wilcoxon signed-rank tests. Additionally, will assess the association between changes in the nodule volume and covariates of interest, including but not excluded to the percentage of volume ablated, the nodule composition at treatment and follow-up, and the amount of energy delivered in Joules.

Will compare symptom scores and cosmetic grades to baseline using Wilcoxon signed-rank tests at both 6 months and at 12 months of follow-up.

Sonographic features will be summarized descriptively.

The cost of ultrasound-guided RFA will be summarized. Comparisons may be made with historical data on the costs associated with surgical thyroidectomy.

M.D. Anderson Cancer Center

Previously collected FNA aspiration specimen samples are analyzed via DDMS assay. Participants undergo FNA aspiration for collection of tissue samples for analysis via DDMS assay.

Diagnostic DNA Methylation Signature

Maria Hahn, PhD

This trial studies how well the diagnostic deoxyribonucleic acid (DNA) methylation signature works in detecting thyroid cancer in patients with thyroid nodules. Using diagnostic testing, such as the diagnostic DNA methylation signature, may be a less invasive way to check for thyroid cancer.

PRIMARY OBJECTIVES:

I. To validate a novel epigenetic thyroid nodule diagnostic test, diagnostic DNA methylation signature (DDMS) in a retrospective-prospective study with leftover of fine needle aspiration biopsies.

OUTLINE:

Previously collected FNA aspiration specimen samples are analyzed via DDMS assay. Participants undergo FNA aspiration for collection of tissue samples for analysis via DDMS assay.

After completion of study, patients are followed up yearly for 5 years.

Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration

Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration in Patients With Thyroid Nodules

Retrospective-Prospective Collection of Thyroid Specimens After FNA

Will be assessed by taking the ratio of the number of thyroid cancer specimens diagnosed as cancer using the DDMS and the total number of thyroid cancer specimens according to the final diagnosis. Will determine the 95% confidence intervals.

Will be assessed by taking the ratio of the number of benign nodules diagnosed by DDMS and the total number of benign thyroid nodule specimens according to the final diagnosis. Will determine the 95% confidence intervals.

Will calculate PPV by dividing the number of true thyroid cancer specimens by the number of thyroid cancer diagnosis by DDMS. Will determine the 95% confidence intervals.

Will calculate NPV by dividing the number of benign nodules by the number of benign diagnosis by DDMS. Will determine the 95% confidence intervals.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ultrasound Elastography in Imaging Patients With Thyroid Nodules	NCT03174925	Malignant Thyro... Thyroid Gland N...	Siemens Acuson ...	18 Years -	Stanford University
Development of Liquid Biopsy Technologies for Noninvasive Cancer Diagnostics in Patients With Suspicious Thyroid Nodules or Thyroid Cancer	NCT04742608	Thyroid Gland C... Thyroid Gland N...	Biospecimen Col... Electronic Heal...	18 Years -	Jonsson Comprehensive Cancer Center
Radiofrequency Ablation for the Treatment of Benign or Low Risk Thyroid Nodule	NCT05003856	Benign Thyroid ... Recurrent Thyro... Thyroid Gland F... Thyroid Gland N... Thyroid Gland P...	Quality-of-Life... Radiofrequency ...	18 Years -	M.D. Anderson Cancer Center
Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration in Patients With Thyroid Nodules	NCT03676647	Thyroid Gland N...	Diagnostic DNA ...	19 Years -	City of Hope Medical Center
Ultrasound Elastography in Imaging Patients With Thyroid Nodules	NCT03174925	Malignant Thyro... Thyroid Gland N...	Siemens Acuson ...	18 Years -	Stanford University

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