Thyroid CancerNCT06443866
I-124 PET/CT Imaging and Dosimetry for RAI-Naïve or Refractory Thyroid Cancer
An observational study of Thyroid Cancer and RAI-Refractory Thyroid Cancer, run by Miami Cancer Research Center, Inc. at 1 site in United States.
Trial summary
The objective of this study is to demonstrate the clinical utility of I-124 PET/CT imaging and dosimetry in patients with thyroid cancer including 1) Evaluation of extent (volume and pattern) of remnant tissue in post total thyroidectomy setting and distinction of nodal metastases vs remnant tissue for determination… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, RAI-Refractory Thyroid Cancer
- What is being tested?
- Disease status detection, Theranostic dosimetry and I-124 PET/CT imaging
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients (18 and older) with thyroid cancer
Who may be able to join
- Post-total thyroidectomy patients with diagnosis of thyroid cancer, any histology, subtype, any ATA risk category, for evaluation for residual disease, cervical or remote metastatic disease
- Patients with known or suspected recurrent/metastatic thyroid cancer, identified by ultrasound (US), CT/MR/FDG-PET|CT or elevated thyroglobulin (Tg).
- Pretreatment and post-treatment evaluation of patients with thyroid cancer deemed RAI-indifferent/refractory who are considered for TKI
- Age ≥ 18
- Ability and willingness to give a written consent
- Life expectancy > 3 months
- ECOG performance status ≤ 2
Who cannot join
- Cancers metastatic to thyroid
- Age < 18
- Inability or unwillingness to give a written consent
- Life expectancy < 3 months
- ECOG performance status ≥ 3
- Pregnant and nursing women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Keila Rios contact
United States1 site, 1 recruiting
- Recruiting
Miami Cancer Research Center
North Miami, Florida, 33181
Seza Gulec, MD, 786-693-0821, sezagulec@gmail.com
About this study
Official title: CLINICAL UTILITY AND FEASIBILITY OF I-124 PET/CT IMAGING AND DOSIMETRY IN PATIENTS WITH THYROID CANCER
The objective of this study is to demonstrate the clinical utility of I-124 PET/CT imaging and dosimetry in patients with thyroid cancer including 1) Evaluation of extent (volume and pattern) of remnant tissue in post total thyroidectomy setting and distinction of nodal metastases vs remnant tissue for determination of indication for RAI ablation, 2) Evaluation of response to RAI remnant ablation, 3) Evaluation for suspected occult recurrent/metastatic disease, 4) Evaluation of extent of disease in patients with known metastatic disease and 5) Evaluation of RAI avidity of recurrent/metastatic thyroid cancer and response to treatment with thyroid kinase inhibitors (TKI).
Patients who underwent total thyroidectomy for thyroid cancers are studied. Patients who are newly diagnosed, as well as those who have known or suspected to have recurrent or metastatic disease are eligible. Patients receiving TKI treatment are eligible for evaluation prior to and after the treatment. The patients who are considered for TKI/MAPK treatments undergo pre and post treatment with clinically determined oncoprotein/TKR therapeutic agent(s), including multi-TKI, selective BRAF, MEK, PI3K or ERK inhibitors or combination treatments.
- Conditions
- Thyroid Cancer, RAI-Refractory Thyroid Cancer
- Being tested
- Disease status detection, Theranostic dosimetry, I-124 PET/CT imaging
- Keywords
- Thyroid Cancer, RAI-Refractory Thyroid Cancer, Redifferentiation Therapy
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disease status detectionDiagnostic test
RAI dose determination
Theranostic dosimetryDiagnostic test
Theranostic dosimetric evaluation for optimization of RAI therapy of thyroid cancer
I-124 PET/CT imagingDrug
Theranostic dosimetry for optimization of RAI therapy for Thyroid Cancer
| Study group | Role | What they receive |
|---|---|---|
| Thyroid Cancer patients, RAI-naive or refractory | Not described Receives: Diagnostic Test: Disease status detection; Diagnostic Test: Theranostic dosimetry; Drug: I-124 PET/CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification and characterization of RAI uptake pattern and kinetics
Measurements:
- Administered activity
- Cumulated activity
- Standard uptake value
Calculations:
- Radiation absorbed dose to the target
Correlations to be reported:
- Administered activity vs absorbed dose
- Absorbed dose vs response
- SUV at 48h vs response
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Feb 2022
- Primary completion31 Jan 2029 (estimated)
- Study completionDec 2029 (estimated)
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.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miami Cancer Research Center, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seza Gulec, MD, Principal investigator, CEO, MCRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443866
- Sponsor's protocol ID
- MTOCP03
- Other IDs
- MBK funding
- Status last verified
- May 2024
- First submitted
- 23 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINICAL UTILITY AND FEASIBILITY OF I-124 PET/CT IMAGING AND DOSIMETRY IN PATIENTS WITH THYROID CANCER
- ClinicalTrials.gov ID
- NCT06443866
- Acronym / sponsor ID
- MTOCP03
- Conditions
- Thyroid Cancer, RAI-Refractory Thyroid Cancer
- Keywords
- Thyroid Cancer, RAI-Refractory Thyroid Cancer, Redifferentiation Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Miami Cancer Research Center, Inc.University, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 5 Jun 2024 (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.
The objective of this study is to demonstrate the clinical utility of I-124 PET/CT imaging and dosimetry in patients with thyroid cancer including 1) Evaluation of extent (volume and pattern) of remnant tissue in post total thyroidectomy setting and distinction of nodal metastases vs remnant tissue for determination of indication for RAI ablation, 2) Evaluation of response to RAI remnant ablation, 3) Evaluation for suspected occult recurrent/metastatic disease, 4) Evaluation of extent of disease in patients with known metastatic disease and 5) Evaluation of RAI avidity of recurrent/metastatic thyroid cancer and response to treatment with thyroid kinase inhibitors (TKI).
Patients who underwent total thyroidectomy for thyroid cancers are studied. Patients who are newly diagnosed, as well as those who have known or suspected to have recurrent or metastatic disease are eligible. Patients receiving TKI treatment are eligible for evaluation prior to and after the treatment. The patients who are considered for TKI/MAPK treatments undergo pre and post treatment with clinically determined oncoprotein/TKR therapeutic agent(s), including multi-TKI, selective BRAF, MEK, PI3K or ERK inhibitors or combination treatments.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thyroid Cancer patients, RAI-naive or refractory | – | Diagnostic Test: Disease status detection, Diagnostic Test: Theranostic dosimetry, Drug: I-124 PET/CT imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18 and older) with thyroid cancer
Key inclusion criteria (7 listed)
- Post-total thyroidectomy patients with diagnosis of thyroid cancer, any histology, subtype, any ATA risk category, for evaluation for residual disease, cervical or remote metastatic disease
- Patients with known or suspected recurrent/metastatic thyroid cancer, identified by ultrasound (US), CT/MR/FDG-PET|CT or elevated thyroglobulin (Tg).
- Pretreatment and post-treatment evaluation of patients with thyroid cancer deemed RAI-indifferent/refractory who are considered for TKI
- Age ≥ 18
- Ability and willingness to give a written consent
Key exclusion criteria (6 listed)
- Cancers metastatic to thyroid
- Age < 18
- Inability or unwillingness to give a written consent
- Life expectancy < 3 months
- ECOG performance status ≥ 3
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 |
|---|---|---|
| Disease status detectionRAI dose determination | Diagnostic test | Thyroid Cancer patients, RAI-naive or refractory |
| Theranostic dosimetryTheranostic dosimetric evaluation for optimization of RAI therapy of thyroid cancer | Diagnostic test | Thyroid Cancer patients, RAI-naive or refractory |
| I-124 PET/CT imagingTheranostic dosimetry for optimization of RAI therapy for Thyroid Cancer | Drug | Thyroid Cancer patients, RAI-naive or refractory |
Primary outcome
Identification and characterization of RAI uptake pattern and kinetics
Time frame: 5 years
Measurements: 1. Administered activity 2. Cumulated activity 3. Standard uptake value Calculations: 1. Radiation absorbed dose to the target Correlations to be reported: 1. Administered activity vs absorbed dose 2. Absorbed dose vs response 3. SUV at 48h vs response
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Keila Rios contact
Seza Gulec, MD principal investigator
CEO, MCRC
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 Cancer and RAI-Refractory Thyroid Cancer, run by Miami Cancer Research Center, Inc. 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 5 Jun 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seza Gulec, MD (786-693-0821, sezagulec@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification and characterization of RAI uptake pattern and kinetics (time frame: 5 years). 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 5 Jun 2024.