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NCT04495985Active, not recruiting

CASE 1320: RAI Uptake and Serum Prolactin in Thyroid Cancer

Breast Uptake on Radioiodine Scan and Serum Prolactin in Thyroid Cancer Patients Prepared by Thyroid Hormone Withdrawal or Recombinant Human Thyrotropin: A Prospective Study

Source: ClinicalTrials.gov · Last updated 28 Jan 2026

Brief summary (registry, in English)

Radioactive iodine (RAI) is a radioisotope used to ablate thyroid gland remnant after thyroidectomy in patients diagnosed with differentiated thyroid carcinoma (DTC). A whole body scan (WBS) is performed to not only evaluate for iodine uptake by the native thyroid tissue but also to observe for uptake in other areas of the body, which could be physiological or indicative of iodide-avid metastases. Research has shown a correlation between breast cancer and thyroid cancer. Patients with DTC have been found to have elevated levels of serum prolactin, which could lead to mammary gland dysfunction. In patients with DTC undergoing RAI scanning or therapy, it has been previously observed that patients prepared by thyroid hormone withdrawal have significantly higher breast uptake on whole body scan compared to those prepared by rh-TSH. Considering the impact of prolactin on breast tissue, this study aims to correlate these findings with the lab values and the method of preparation. Accordingly, the research question is as follows: does the method of WBS preparation impact prolactin levels and how does that correlate with breast uptake in patients with DTC undergoing RAI WBS?

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
39 (actual)
First submitted
10 Jun 2020
Start date
14 Jul 2020
Primary completion date
27 Jul 2022
Lead sponsor
The Cleveland Clinic
NCT number
NCT04495985

What you commit to

  • Study type: Observational
  • Participants enrolled: 39
  • From 14 Jul 2020 to the primary completion date, 27 Jul 2022
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with a history of breast cancer
  • Patients with a known history of hyperprolactinemia

Lab values

  • Patients receiving medications known to raise serum prolactin

Other

  • Males

Who the study is looking for

  • Female patients with diagnosis of differentiated thyroid carcinoma who have had thyroidectomy performed previously
  • Patients able to understand and sign informed consent for imaging
  • Patients already scheduled to undergo radioactive iodine whole body scanning (RAI WBS)

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cleveland Clinic
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.