NCT00001160

Brief Summary

Participants in this study will be patients diagnosed with or suspected to have a thyroid nodule or thyroid cancer. The main purpose of this study is to further understand the methods for the diagnosis and treatment of thyroid nodules and thyroid cancer. Many of the test performed are in the context of standard medical care that is offered to all patients with thyroid nodules or thyroid cancer. Other tests are performed for research purposes. In addition, blood and tissue samples will be taken for research and genetic studies.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1977

Completed
22.4 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
Last Updated

May 7, 2026

Status Verified

February 12, 2026

First QC Date

November 3, 1999

Last Update Submit

May 6, 2026

Conditions

Keywords

Thyroid Fine Needle BiopsyRadioiodineDosimetryNatural History

Outcome Measures

Primary Outcomes (2)

  • Evaluation of thyroid cancer

    Blood draws, CT and other scans, physical exams, surgery (if applicable), thyroid biopsy (if applicable).

    As clinically indicated

  • Evaluation of thyroid disorders

    blood draws, CT and other scans, physical exam.

    As clinically indicated

Study Arms (2)

thyroid cancer

Patients with thyroid cancer

Drug: 68-Gallium Dotatate

thyroid nodules

Patients with thyroid nodules

Drug: 68-Gallium Dotatate

Interventions

For evaluation risk/benefit evaluation

thyroid cancerthyroid nodules

Eligibility Criteria

Age6 Months - 98 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Only those with thyroid nodules and/or thyroid cancer will be allowed to enroll.

You may qualify if:

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Male or female, adults or children \>= 6 months+.
  • Patients with known or suspected thyroid nodules and/or thyroid cancer.
  • At risk family members of patients who have a genetic susceptibility to developing thyroid cancer.

You may not qualify if:

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • \. Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma requiring intervention before thyroid cancer is addressed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (2)

  • Klubo-Gwiezdzinska J, Wartofsky L. The Role of Molecular Diagnostics in the Management of Indeterminate Thyroid Nodules. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3507-3510. doi: 10.1210/jc.2018-01081.

    PMID: 30032182BACKGROUND
  • Thakur S, Tobey A, Daley B, Auh S, Walter M, Patel D, Nilubol N, Kebebew E, Patel A, Jensen K, Vasko V, Klubo-Gwiezdzinska J. Limited Utility of Circulating Cell-Free DNA Integrity as a Diagnostic Tool for Differentiating Between Malignant and Benign Thyroid Nodules With Indeterminate Cytology (Bethesda Category III). Front Oncol. 2019 Sep 18;9:905. doi: 10.3389/fonc.2019.00905. eCollection 2019.

    PMID: 31620364BACKGROUND

Related Links

MeSH Terms

Conditions

Thyroid cancer, Hurthle cellAdenocarcinoma, FollicularThyroid NeoplasmsThyroid Cancer, Papillary

Interventions

gallium Ga 68 dotatate

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesAdenocarcinoma, Papillary

Study Officials

  • Joanna Klubo-Gwiezdzinska, M.D.

    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Padmasree Veeraraghavan, R.N.

CONTACT

Joanna Klubo-Gwiezdzinska, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

June 1, 1977

Last Updated

May 7, 2026

Record last verified: 2026-02-12

Locations