Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443866
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-23
Brief Title:
I-124 PETCT Imaging and Dosimetry for RAI-Naïve or Refractory Thyroid Cancer
Sponsor:
Miami Cancer Research Center Inc
Organization:
Miami Cancer Research Center Inc
Study Overview
Official Title:
CLINICAL UTILITY AND FEASIBILITY OF I-124 PETCT IMAGING AND DOSIMETRY IN PATIENTS WITH THYROID CANCER
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to demonstrate the clinical utility of I-124 PETCT 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 recurrentmetastatic disease 4 Evaluation of extent of disease in patients with known metastatic disease and 5 Evaluation of RAI avidity of recurrentmetastatic 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 TKIMAPK treatments undergo pre and post treatment with clinically determined oncoproteinTKR therapeutic agents including multi-TKI selective BRAF MEK PI3K or ERK inhibitors or combination treatments
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 TKIMAPK treatments undergo pre and post treatment with clinically determined oncoproteinTKR therapeutic agents including multi-TKI selective BRAF MEK PI3K or ERK inhibitors or combination treatments
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MBK funding | OTHER | MiamiCancerRC | None |