Thyroid CarcinomaRETENTIONNCT02773667
Renal Tracer Elimination in Thyroid Cancer Patients Treated With 131-Iodine
An observational study of Thyroid Carcinoma, run by Jena University Hospital at 1 site in Germany.
Trial summary
Correlation analysis between estimated renal function and biological half life of 131-I during radioiodine treatment of patients with differentiated thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Carcinoma
- How many people
- 83 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to Dec 2022
- 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: Patients with histological secured differentiated thyroid cancer stationary for treatment or diagnostic with radioiodine
Who may be able to join
- patients with differentiated thyroid carcinoma
- stationary for treatment or diagnostic with radioiodine
- state after thyroidectomy
- written consent of the patient
- minimum age 18 years
- patients without TSH-stimulation by rhTSH
Who cannot join
- no written consent of the patient
- patients with large residual thyroid tissue (iodine uptake > 10%)
- children under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Estimated Glomerular Filtration Rate and Biological Half-life of 131I. Prospective Analysis in Patients With Differentiated Thyroid Carcinoma.
Correlation analysis between estimated renal function and biological half life of 131-I during radioiodine treatment of patients with differentiated thyroid cancer.
Read the detailed description
131-I during radioiodine treatment of patients with differentiated thyroid cancer is mainly renally excreted. It is advised in the clinical guidelines that serum creatinine should be determined before applying 131-I and if necessary the administered dose should be reduced. Nevertheless no guideline gives advice in what extent the dose should be decreased. The adjustment is at the discretion of the attending physician.
Aim of this prospective study is to correlate the biological half life of 131-I with the renal function to give objective recommendations concerning the reduction of the applied dose in patients with limited renal function.
- Conditions
- Thyroid Carcinoma
- Medical subject headings
- Thyroid Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between estimated renal function and biological half life of 131-I
The estimated renal function (estimated GFR) is measured via determination of serum creatinine and Cystatin C.
The biological half-life of I-131 is determined via whole-body dosimetry (whole-body probe and whole-body gamma camera) and blood probe measurement.
Update 2017/06/07: After analyzing the preliminary results (based on the first 48 patients) probe measurements are not longer needed in a simplified study design. Additionally, measuring the creatinine concentration is no longer needed in comparison to the Cystatin C measurements.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CarcinomaStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Freesmeyer, Dr. med., Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773667
- Sponsor's protocol ID
- I-131-07/2015
- Acronym
- RETENTION
- Status last verified
- Dec 2022
- First submitted
- 11 May 2016
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Estimated Glomerular Filtration Rate and Biological Half-life of 131I. Prospective Analysis in Patients With Differentiated Thyroid Carcinoma.
- ClinicalTrials.gov ID
- NCT02773667
- Acronym / sponsor ID
- RETENTION / I-131-07/2015
- Conditions
- Thyroid Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 16 May 2016 (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.
Correlation analysis between estimated renal function and biological half life of 131-I during radioiodine treatment of patients with differentiated thyroid cancer.
Detailed description
131-I during radioiodine treatment of patients with differentiated thyroid cancer is mainly renally excreted. It is advised in the clinical guidelines that serum creatinine should be determined before applying 131-I and if necessary the administered dose should be reduced. Nevertheless no guideline gives advice in what extent the dose should be decreased. The adjustment is at the discretion of the attending physician.
Aim of this prospective study is to correlate the biological half life of 131-I with the renal function to give objective recommendations concerning the reduction of the applied dose in patients with limited renal function.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histological secured differentiated thyroid cancer stationary for treatment or diagnostic with radioiodine
Key inclusion criteria (6 listed)
- patients with differentiated thyroid carcinoma
- stationary for treatment or diagnostic with radioiodine
- state after thyroidectomy
- written consent of the patient
- minimum age 18 years
Key exclusion criteria (3 listed)
- no written consent of the patient
- patients with large residual thyroid tissue (iodine uptake > 10%)
- children under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between estimated renal function and biological half life of 131-I
Time frame: 2 years
The estimated renal function (estimated GFR) is measured via determination of serum creatinine and Cystatin C. The biological half-life of I-131 is determined via whole-body dosimetry (whole-body probe and whole-body gamma camera) and blood probe measurement. Update 2017/06/07: After analyzing the preliminary results (based on the first 48 patients) probe measurements are not longer needed in a simplified study design. Additionally, measuring the creatinine concentration is no longer needed in comparison to the Cystatin C measurements.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- 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. This study is not recruiting at the moment.
Martin Freesmeyer, Dr. med. principal investigator
Study Principal Investigator
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 Carcinoma, run by Jena University Hospital at 1 site in Germany.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 16 Dec 2022. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between estimated renal function and biological half life of 131-I (time frame: 2 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 16 Dec 2022.