Thyroid Gland Follicular CarcinomaNCT05591092
Radioiodine Planar and a SPECT/CT Imaging With Iodine-123 for Evaluation of Follicular Thyroid Nodules Prior to Surgery
An observational study of Thyroid Gland Follicular Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This study evaluates radioiodine planar and SPECT/CT imaging with iodine-123 in patients with follicular thyroid nodules prior to surgery. Because biopsy alone is not sufficient to distinguish between malignant follicular thyroid nodules and benign follicular thyroid nodules, patients with follicular thyroid lesions… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Gland Follicular Carcinoma
- What is being tested?
- Computed Tomography, Iodine I-123 and Planar Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2023to 21 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mayo Clinic patients with biopsy-proven indeterminate follicular thyroid lesions scheduled for surgery.
Who may be able to join
- Age \> 18 years
- Any gender
- Patients will have had no therapy for their thyroid nodule prior to enrollment
- Negative urine pregnancy test within 48 hours before the administration of radiopharmaceutical in women of childbearing potential
- Follicular neoplasm or suspicious of follicular neoplasm, cytopathology on biopsy of thyroid nodule
- Any outside fine needle aspiration (FNA) reports are to be reviewed by a Mayo pathologist
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- Nodules 1-4 cm with solid appearance on ultrasound
- Ultrasound images and report documented in medical record, including the size of the nodule and location (upper, mid or lower portion of the thyroid lobe)
- At least 2/3 of either thyroid lobe without nodules should be present to allow for the measurement of uptake in unaffected thyroid tissue
- Thyroid stimulating hormone (TSH) 0.3-3.0 mIU/L
- Patient is scheduled or being considered for surgical resection of the nodule
- I-123 planar and Single Photon Emission Computed Tomography (SPECT)/Computed Tomography (CT) can be scheduled at least 2 days after biopsy and before surgery
Who cannot join
- Recent iodinated contrast, including intravenous (IV) and oral CT contrast or interventional vascular or cardiac study (within 6 weeks)
- Hurthle cell adenoma
- Current thyroid hormone supplementation
- Current use of anti-thyroid medications (methimazole or propylthiouracyl)
- Less than 2 days after thyroid nodule FNA/biopsy
- Presence of another nodule of similar size in the same area of thyroid lobe, which could impair localization of the nodule on SPECT/CT images
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- Less than 2/3 of normal thyroid tissue present in either thyroid lobe without nodules
- Positive pregnancy test
- All women who are breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Radioiodine Scanning for Pre-Surgical Evaluation of Follicular Thyroid Nodules
This study evaluates radioiodine planar and SPECT/CT imaging with iodine-123 in patients with follicular thyroid nodules prior to surgery. Because biopsy alone is not sufficient to distinguish between malignant follicular thyroid nodules and benign follicular thyroid nodules, patients with follicular thyroid lesions are referred for surgery for further evaluation. A non-invasive imaging method that can accurately determine malignancy in follicular thyroid nodules would be valuable in patient management and could potentially spare patients unnecessary surgery. Planar imagine uses a gamma camera to obtain 2D images and SPECT/CT imaging is a special type of CT scan in which a small amount of a radioactive drug is injected into a vein and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the tumor cells. Radioiodine planar and SPECT/CT imaging may be more accurate in distinguishing between benign follicular thyroid nodules and malignant follicular thyroid nodules to help reduce the need for surgery.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the proportion of benign nodules appearing as hot/warm on radioiodine scans (nodule uptake \>= uptake in normal thyroid tissues).
II. To identify a possible relationship between iodine-123 (I-123) uptake on planar and single-photon emission computerized tomography (SPECT)/computerized tomography (CT) images and malignancy on surgical pathology in thyroid nodules that were previously identified by fine-needle aspiration (FNA) as indeterminate follicular neoplasm.
III. Examine correlations between intensity of uptake in follicular nodules before surgery (standard uptake values [SUV] on the quantitative reconstructions from our Veriton SPECT/CT scanner and nodule-to-normal thyroid background ratios on planar and SPECT images) and pathology findings and determine a SUV threshold that best distinguishes between benign and malignant nodules.
IV. Compare the usefulness of conventional planar imaging versus SPECT/CT imaging for thyroid nodules, in order to inform our optimal clinical protocol.
- Establish an imaging protocol best suited for measuring uptake in small thyroid nodules.
OUTLINE:
Patients receive iodine-123 orally (PO) and then undergo planar imaging and a SPECT/CT scan on study.
- Conditions
- Thyroid Gland Follicular Carcinoma
- Being tested
- Computed Tomography, Iodine I-123, Planar Imaging, Single Photon Emission Computed Tomography
- Medical subject headings
- Adenocarcinoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo a SPECT/CT scan
Iodine I-123Radiation
Also called I-123, Iodine 123, Iodine I 123, Isotope of Mass 123
Given PO
Planar ImagingProcedure or surgery
Undergo planar imaging
Single Photon Emission Computed TomographyProcedure or surgery
Also called Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECT
Undergo a SPECT/CT scan
| Study group | Role | What they receive |
|---|---|---|
| Observational (I-123, planar imaging, SPECT/CT scan) | Patients receive iodine-123 PO and then undergo planar imaging and a SPECT/CT scan on study. Receives: Procedure: Computed Tomography; Radiation: Iodine I-123; Procedure: Planar Imaging; Procedure: Single Photon Emission Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Adverse events will be assessed while patients are in the nuclear medicine division undergoing positron emission tomography/computed tomography imaging.
Measured: Up to study completion, up to one year
Iodine-123 uptake
We will compare the intensity of uptake in malignant versus benign lesions.
Measured: Up to study completion; up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start10 Nov 2023
- Primary completion21 Jan 2025
- Study completion21 Jan 2025
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Gland Follicular CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jolanta M. Durski, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591092
- Sponsor's protocol ID
- 20-010663
- Other IDs
- NCI-2022-03573
- Status last verified
- Apr 2025
- First submitted
- 18 Oct 2022
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radioiodine Scanning for Pre-Surgical Evaluation of Follicular Thyroid Nodules
- ClinicalTrials.gov ID
- NCT05591092
- Acronym / sponsor ID
- 20-010663
- Conditions
- Thyroid Gland Follicular Carcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates radioiodine planar and SPECT/CT imaging with iodine-123 in patients with follicular thyroid nodules prior to surgery. Because biopsy alone is not sufficient to distinguish between malignant follicular thyroid nodules and benign follicular thyroid nodules, patients with follicular thyroid lesions are referred for surgery for further evaluation. A non-invasive imaging method that can accurately determine malignancy in follicular thyroid nodules would be valuable in patient management and could potentially spare patients unnecessary surgery. Planar imagine uses a gamma camera to obtain 2D images and SPECT/CT imaging is a special type of CT scan in which a small amount of a radioactive drug is injected into a vein and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the tumor cells. Radioiodine planar and SPECT/CT imaging may be more accurate in distinguishing between benign follicular thyroid nodules and malignant follicular thyroid nodules to help reduce the need for surgery.
Detailed description
PRIMARY OBJECTIVES:
- Determine the proportion of benign nodules appearing as hot/warm on radioiodine scans (nodule uptake \>= uptake in normal thyroid tissues).
II. To identify a possible relationship between iodine-123 (I-123) uptake on planar and single-photon emission computerized tomography (SPECT)/computerized tomography (CT) images and malignancy on surgical pathology in thyroid nodules that were previously identified by fine-needle aspiration (FNA) as indeterminate follicular neoplasm.
III. Examine correlations between intensity of uptake in follicular nodules before surgery (standard uptake values [SUV] on the quantitative reconstructions from our Veriton SPECT/CT scanner and nodule-to-normal thyroid background ratios on planar and SPECT images) and pathology findings and determine a SUV threshold that best distinguishes between benign and malignant nodules.
IV. Compare the usefulness of conventional planar imaging versus SPECT/CT imaging for thyroid nodules, in order to inform our optimal clinical protocol.
- Establish an imaging protocol best suited for measuring uptake in small thyroid nodules.
OUTLINE:
Patients receive iodine-123 orally (PO) and then undergo planar imaging and a SPECT/CT scan on study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (I-123, planar imaging, SPECT/CT scan) | – | Procedure: Computed Tomography, Radiation: Iodine I-123, Procedure: Planar Imaging, Procedure: Single Photon Emission Computed TomographyPatients receive iodine-123 PO and then undergo planar imaging and a SPECT/CT scan on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mayo Clinic patients with biopsy-proven indeterminate follicular thyroid lesions scheduled for surgery.
Key inclusion criteria (12 listed)
- Age \> 18 years
- Any gender
- Patients will have had no therapy for their thyroid nodule prior to enrollment
- Negative urine pregnancy test within 48 hours before the administration of radiopharmaceutical in women of childbearing potential
- Follicular neoplasm or suspicious of follicular neoplasm, cytopathology on biopsy of thyroid nodule
Key exclusion criteria (9 listed)
- Recent iodinated contrast, including intravenous (IV) and oral CT contrast or interventional vascular or cardiac study (within 6 weeks)
- Hurthle cell adenoma
- Current thyroid hormone supplementation
- Current use of anti-thyroid medications (methimazole or propylthiouracyl)
- Less than 2 days after thyroid nodule FNA/biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo a SPECT/CT scan | Procedure or surgery | Observational (I-123, planar imaging, SPECT/CT scan) |
| Iodine I-123Also: I-123, Iodine 123, Iodine I 123, Isotope of Mass 123Given PO | Radiation | Observational (I-123, planar imaging, SPECT/CT scan) |
| Planar ImagingUndergo planar imaging | Procedure or surgery | Observational (I-123, planar imaging, SPECT/CT scan) |
| Single Photon Emission Computed TomographyAlso: Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECTUndergo a SPECT/CT scan | Procedure or surgery | Observational (I-123, planar imaging, SPECT/CT scan) |
Primary outcome
Incidence of adverse events
Time frame: Up to study completion, up to one year
Adverse events will be assessed while patients are in the nuclear medicine division undergoing positron emission tomography/computed tomography imaging.
Iodine-123 uptake
Time frame: Up to study completion; up to one year
We will compare the intensity of uptake in malignant versus benign lesions.
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jolanta M. Durski, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Gland Follicular Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to study completion, up to one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.