NCT04141306

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

1 month

First QC Date

October 22, 2019

Last Update Submit

October 25, 2019

Conditions

Keywords

Radioiodine Bone MetastasesThyroid Cancer

Outcome Measures

Primary Outcomes (1)

  • 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)

    1 month

Interventions

Evaluation of month and year of birth, sex, referent doctor and surgeon

Evaluation of diagnostic circumstances, vital status at last follow up

Evaluation of Pathology report of thyroid surgery

Evaluation of scintigraphy, MRI, scan

Evaluation of thyroglobulin, antithyroglobulin antibodies

Evaluation of surgery, radiotherapy, targeted therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Differentiated thyroid cancer
  • Ablation therapy with post dose scintigraphy
  • At least one radioiodine bone uptake without structural correlation on high-resolution imaging

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Routinely Collected Health Data

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Health Care SurveysHealth Services ResearchHealth PlanningHealth Care Economics and OrganizationsHealth Care Quality, Access, and Evaluation

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 28, 2019

Study Start

November 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

October 28, 2019

Record last verified: 2019-10