Thyroid CancerNCT00373711
Comparison of I-124 PET/CT, F-18 FDG PET/CT & I-123 Whole Body Scintigraphy for Recurrent Thyroid CA
An observational study of Thyroid Cancer, run by Stanford University.
Trial summary
The management of thyroid cancer patients with suspicion of recurrent disease based on rising/detectable levels of thyroglobulin (Tg) involves imaging with iodine-123 whole body scintigraphy (I-123 WBS) and F-18 FDG PET/CT. However, the disease is not always detected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Iodine-124, Iodine-123 and F-18 FDG
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2007to not given
- 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: Participants with Thyroid cancer
Inclusion Criteria:- Patient at Nuclear Medicine clinic at Stanford University Medical Center
- Treated thyroid cancer.
- Detectable levels of Tg.
- Referred for I-123 WBS and F-18 FDG PET/CT for detection of recurrent thyroid cancer.
- Able to have a I-124 PET/CT the day after I-123 WBS and F-18 FDG PET/CT
- Patients older than 18-year-old.
- Patients with history of treated thyroid cancer and suspected recurrent thyroid cancer based on detectable levels of Tg.
- Patients must have I-123 WBS and F-18 FDG PET/CT performed prior to the I-124 PET/CT.
- Patients must understand and voluntarily sign an Informed Consent form after the contents have been fully explained to them. Exclusion Criteria:- Patients who are not eligible for I-123 WBS and F-18 FDG PET/CT.
- Patients who cannot complete I-123 WBS and F-18 FDG PET/CT.
- Pregnant women.
- Healthy volunteers.
- Patients participating in other research studies.
About this study
Official title: Comparison of I-124 PET/CT, F-18 FDG PET/CT and I-123 Whole Body Scintigraphy for Recurrent Thyroid Cancer Detection
The management of thyroid cancer patients with suspicion of recurrent disease based on rising/detectable levels of thyroglobulin (Tg) involves imaging with iodine-123 whole body scintigraphy (I-123 WBS) and F-18 FDG PET/CT. However, the disease is not always detected. The use of another iodine isotope (I-124) with positron emitting characteristics for PET/CT may allow better identification of recurrent disease, thus allowing for more patients to be treated with I-131 as a curative attempt.
Read the detailed description
The management of thyroid cancer patients with suspicion of recurrent disease based on rising/detectable levels of thyroglobulin (Tg) involves imaging with iodine-123 whole body scintigraphy (I-123 WBS) and F-18 FDG PET/CT. However, the disease is not always detected. The use of another iodine isotope (I-124) with positron emitting characteristics for PET/CT may allow better identification of recurrent disease, thus allowing for more patients to be treated with I-131 as a curative attempt.
Conducting this study we hope to find whether I-124 PET/CT allows for detection of more lesions in patients with suspected recurrent thyroid cancer than the current standard of care represented by I-123 WBS and F-18 FDG PET/CT.
- Conditions
- Thyroid Cancer
- Being tested
- Iodine-124, Iodine-123, F-18 FDG
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine-124Drug
Also called Eastern Isotopes
2 mCi, oral
Iodine-123Drug
Also called MDS Nordion
2 mCi, oral
F-18 FDGDrug
Also called Fludeoxyglucose (18 F), fluorodeoxyglucose (18 F), MIPS
10-15 mCi, iv
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startMay 2007
Why it stopped: Abandoned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Investigators
- Andrei Iagaru, Principal investigator, Stanford UniversityIain Ross McDougall, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373711
- Sponsor's protocol ID
- END0003
- Other IDs
- 97454, END0003
- Status last verified
- Apr 2011
- First submitted
- 6 Sep 2006
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of I-124 PET/CT, F-18 FDG PET/CT and I-123 Whole Body Scintigraphy for Recurrent Thyroid Cancer Detection
- ClinicalTrials.gov ID
- NCT00373711
- Acronym / sponsor ID
- END0003
- Conditions
- Thyroid Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Abandoned
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- May 2007
- First posted
- 8 Sep 2006 (estimated)
- 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.
The management of thyroid cancer patients with suspicion of recurrent disease based on rising/detectable levels of thyroglobulin (Tg) involves imaging with iodine-123 whole body scintigraphy (I-123 WBS) and F-18 FDG PET/CT. However, the disease is not always detected. The use of another iodine isotope (I-124) with positron emitting characteristics for PET/CT may allow better identification of recurrent disease, thus allowing for more patients to be treated with I-131 as a curative attempt.
Detailed description
The management of thyroid cancer patients with suspicion of recurrent disease based on rising/detectable levels of thyroglobulin (Tg) involves imaging with iodine-123 whole body scintigraphy (I-123 WBS) and F-18 FDG PET/CT. However, the disease is not always detected. The use of another iodine isotope (I-124) with positron emitting characteristics for PET/CT may allow better identification of recurrent disease, thus allowing for more patients to be treated with I-131 as a curative attempt.
Conducting this study we hope to find whether I-124 PET/CT allows for detection of more lesions in patients with suspected recurrent thyroid cancer than the current standard of care represented by I-123 WBS and F-18 FDG PET/CT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with Thyroid cancer
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 |
|---|---|---|
| Iodine-124Also: Eastern Isotopes2 mCi, oral | Drug | – |
| Iodine-123Also: MDS Nordion2 mCi, oral | Drug | – |
| F-18 FDGAlso: Fludeoxyglucose (18 F), fluorodeoxyglucose (18 F), MIPS10-15 mCi, iv | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
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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.
Andrei Iagaru principal investigator
Stanford University
Iain Ross McDougall principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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.
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 21 Jun 2022.