Radioiodine-avid Bone Metastases From Thyroid Cancer Without Structural Abnormality

Thyroid Cancer Clinical Trial

Official title:

Radioiodine-avid Bone Metastases From Differentiated Thyroid Cancer Without Structural Abnormality, a Singular Entity With Heterogeneous Outcomes.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04141306
• Other study ID #: 69HCL19_1919
• Status: Not yet recruiting
• Start date: November 2019
• Est. completion date: December 2019

Study information

• Verified date: October 2019
• Source: Hospices Civils de Lyon
• Contact: Claire BOURNAUD, MD
• Phone: 4 72 35 69 99
• Email: claire.bournaud-salinas[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Differentiated thyroid cancer

• Ablation therapy with post dose scintigraphy

• At least one radioiodine bone uptake without structural correlation on high-resolution imaging

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Other:
• Administrative data
Evaluation of month and year of birth, sex, referent doctor and surgeon
• Clinical data
Evaluation of diagnostic circumstances, vital status at last follow up
• Histological data
Evaluation of Pathology report of thyroid surgery
• Imaging data
Evaluation of scintigraphy, MRI, scan
• Biological data
Evaluation of thyroglobulin, antithyroglobulin antibodies
• Further treatment
Evaluation of surgery, radiotherapy, targeted therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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