Bone MetastasesNCT04141306
Radioiodine-avid Bone Metastases From Thyroid Cancer Without Structural Abnormality
An observational study of Bone Metastases and Thyroid Cancer, run by Hospices Civils de Lyon.
Trial summary
Bone radioiodine (RAI) uptake without structural abnormality in thyroid cancer (TC) patients may be related to false positive or to microscopic foci of metastatic tissue. In such cases, outcome is reported to be excellent. Indeed, Robenshtok et al. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bone Metastases, Thyroid Cancer
- What is being tested?
- Administrative data, Clinical data and Histological data
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Dec 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who received total thyroidectomy in a context of differentiated thyroid cancer showing at post-therapy scintigraphy at least one radioiodine bone uptake without structural correlation on high-resolution imaging
Who may be able to join
- Differentiated thyroid cancer
- Ablation therapy with post dose scintigraphy
- At least one radioiodine bone uptake without structural correlation on high-resolution imaging
Who cannot join
- A single radio iodine bone uptake with structural correlation on imaging
- Diagnosis of bone metastasis after a skeletal related event including spinal cord compression, pathological fracture, need for external beam radiation, surgery to bone, or development of hypercalcemia of malignancy
- Follow up less than 6 months
- Missing data in medical record
Trial locations and contacts
No sites are listed yet.
Claire MARX contact
About this study
Official title: Radioiodine-avid Bone Metastases From Differentiated Thyroid Cancer Without Structural Abnormality, a Singular Entity With Heterogeneous Outcomes.
Bone radioiodine (RAI) uptake without structural abnormality in thyroid cancer (TC) patients may be related to false positive or to microscopic foci of metastatic tissue. In such cases, outcome is reported to be excellent.
Indeed, Robenshtok et al. reported a serie of patients with RAI-avid bone metastases of TC without structural abnormality on imaging studies who have more favorable long-term prognosis than those harbouring structurally visible bone metastases and do not undergo skeletal-related complications.
Read more
The investigators report the case of Mrs D., who had been operated for a pathologic tumor stage 3: pT3(m) poorly differentiated TC at the age of 43. The first post-therapeutic whole body scan revealed 3 foci of bone uptake (right clavicle, L2, L3). The elevated level of thyroglobulin (157ng/mL) favoured the hypothesis of bone metastases despite the absence of any structural lesion on CT and MRI. She received 7 courses of radioiodine therapy. The right clavicle RAI uptake persisted, and subsequent CT disclosed an osteolytic lesion which was treated by radiofrequency and external beam radiation. Twenty-five years after the diagnosis, she has a persistent morphological disease with a 30x8mm progressive lesion on the right clavicle, for which surgery is planned.
The aim of the present study is to describe the natural history and evolution of radioiodine avid bone metastases from thyroid cancer without structural abnormalities and to identify prognosis factors.
- Conditions
- Bone Metastases, Thyroid Cancer
- Being tested
- Administrative data, Clinical data, Histological data, Imaging data, Biological data
- Keywords
- Radioiodine Bone Metastases, Thyroid Cancer
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administrative dataOther
Evaluation of month and year of birth, sex, referent doctor and surgeon
Clinical dataOther
Evaluation of diagnostic circumstances, vital status at last follow up
Histological dataOther
Evaluation of Pathology report of thyroid surgery
Imaging dataOther
Evaluation of scintigraphy, MRI, scan
Biological dataOther
Evaluation of thyroglobulin, antithyroglobulin antibodies
Further treatmentOther
Evaluation of surgery, radiotherapy, targeted therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete remission of thyroid cancer
- Disappearance of pathologic radio iodine uptake, including bone uptake, on post-therapy scintigraphy
- No structural evidence of disease on high-resolution imaging
- Suppressed serum Tg < 0.6 ng/mL, no detectable TgAb (thyroglobulin antibody)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study startNov 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141306
- Sponsor's protocol ID
- 69HCL19_1919
- Status last verified
- Oct 2019
- First submitted
- 22 Oct 2019
- Last updated
- 28 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radioiodine-avid Bone Metastases From Differentiated Thyroid Cancer Without Structural Abnormality, a Singular Entity With Heterogeneous Outcomes.
- ClinicalTrials.gov ID
- NCT04141306
- Acronym / sponsor ID
- 69HCL19_1919
- Conditions
- Bone Metastases, Thyroid Cancer
- Keywords
- Radioiodine Bone Metastases, Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 Oct 2019 (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.
Bone radioiodine (RAI) uptake without structural abnormality in thyroid cancer (TC) patients may be related to false positive or to microscopic foci of metastatic tissue. In such cases, outcome is reported to be excellent.
Indeed, Robenshtok et al. reported a serie of patients with RAI-avid bone metastases of TC without structural abnormality on imaging studies who have more favorable long-term prognosis than those harbouring structurally visible bone metastases and do not undergo skeletal-related complications.
The investigators report the case of Mrs D., who had been operated for a pathologic tumor stage 3: pT3(m) poorly differentiated TC at the age of 43. The first post-therapeutic whole body scan revealed 3 foci of bone uptake (right clavicle, L2, L3). The elevated level of thyroglobulin (157ng/mL) favoured the hypothesis of bone metastases despite the absence of any structural lesion on CT and MRI. She received 7 courses of radioiodine therapy. The right clavicle RAI uptake persisted, and subsequent CT disclosed an osteolytic lesion which was treated by radiofrequency and external beam radiation. Twenty-five years after the diagnosis, she has a persistent morphological disease with a 30x8mm progressive lesion on the right clavicle, for which surgery is planned.
The aim of the present study is to describe the natural history and evolution of radioiodine avid bone metastases from thyroid cancer without structural abnormalities and to identify prognosis factors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received total thyroidectomy in a context of differentiated thyroid cancer showing at post-therapy scintigraphy at least one radioiodine bone uptake without structural correlation on high-resolution imaging
Key inclusion criteria (3 listed)
- Differentiated thyroid cancer
- Ablation therapy with post dose scintigraphy
- At least one radioiodine bone uptake without structural correlation on high-resolution imaging
Key exclusion criteria (4 listed)
- A single radio iodine bone uptake with structural correlation on imaging
- Diagnosis of bone metastasis after a skeletal related event including spinal cord compression, pathological fracture, need for external beam radiation, surgery to bone, or development of hypercalcemia of malignancy
- Follow up less than 6 months
- Missing data in medical record
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 |
|---|---|---|
| Administrative dataEvaluation of month and year of birth, sex, referent doctor and surgeon | Other | – |
| Clinical dataEvaluation of diagnostic circumstances, vital status at last follow up | Other | – |
| Histological dataEvaluation of Pathology report of thyroid surgery | Other | – |
| Imaging dataEvaluation of scintigraphy, MRI, scan | Other | – |
| Biological dataEvaluation of thyroglobulin, antithyroglobulin antibodies | Other | – |
| Further treatmentEvaluation of surgery, radiotherapy, targeted therapy | Other | – |
Primary outcome
Rate of complete remission of thyroid cancer
Time frame: 1 month
* Disappearance of pathologic radio iodine uptake, including bone uptake, on post-therapy scintigraphy * No structural evidence of disease on high-resolution imaging * Suppressed serum Tg < 0.6 ng/mL, no detectable TgAb (thyroglobulin antibody)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
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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.
Claire MARX contact
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Metastases and Thyroid Cancer, run by Hospices Civils de Lyon.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire BOURNAUD, MD (4 72 35 69 99 ext. +33, claire.bournaud-salinas@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complete remission of thyroid cancer (time frame: 1 month). 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 28 Oct 2019.