Comparison of I-124 PET/CT, F-18 FDG PET/CT & I-123 Whole... | NCT00373711

Studies
Comparison of I-124 PET/CT, F-18 FDG PET/CT & I-123 Whole Body Scintigraphy for Recurrent Thyroid CA

NCT00373711

Sponsor

Stanford University

Status

Withdrawn

Last Update Posted

Jun 21, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Thyroid Cancer

Interventions

Iodine-124
Iodine-123
F-18 FDG

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
97454	Other Identifier	Stanford University Alternate IRB Approval Number
END0003	Other Identifier	Stanford University

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Abandoned

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 6, 2006

First Submission Date that Met QC Criteria

Sep 6, 2006

First Posted Date

Sep 8, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2022

Last Update Posted Date

Jun 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The management of thyroid cancer patients with suspicion of recurrent disease based on rising/detectable levels of thyroglobulin (Tg) involves imaging with iodine-123 whole body scintigraphy (I-123 WBS) and F-18 FDG PET/CT. However, the disease is not always detected. The use of another iodine isotope (I-124) with positron emitting characteristics for PET/CT may allow better identification of recurrent disease, thus allowing for more patients to be treated with I-131 as a curative attempt.

Detailed Description

Conducting this study we hope to find whether I-124 PET/CT allows for detection of more lesions in patients with suspected recurrent thyroid cancer than the current standard of care represented by I-123 WBS and F-18 FDG PET/CT.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Other Names
Iodine-124	Drug	2 mCi, oral	Eastern Isotopes
Iodine-123	Drug	2 mCi, oral	MDS Nordion
F-18 FDG	Drug	10-15 mCi, iv	Fludeoxyglucose (18 F) fluorodeoxyglucose (18 F) MIPS

Eligibility Module

Eligibility Criteria

Inclusion Criteria:- Patient at Nuclear Medicine clinic at Stanford University Medical Center

Treated thyroid cancer.
Detectable levels of Tg.
Referred for I-123 WBS and F-18 FDG PET/CT for detection of recurrent thyroid cancer.
Able to have a I-124 PET/CT the day after I-123 WBS and F-18 FDG PET/CT
Patients older than 18-year-old.
Patients with history of treated thyroid cancer and suspected recurrent thyroid cancer based on detectable levels of Tg.
Patients must have I-123 WBS and F-18 FDG PET/CT performed prior to the I-124 PET/CT.
Patients must understand and voluntarily sign an Informed Consent form after the contents have been fully explained to them. Exclusion Criteria:- Patients who are not eligible for I-123 WBS and F-18 FDG PET/CT.
Patients who cannot complete I-123 WBS and F-18 FDG PET/CT.
Pregnant women.
Healthy volunteers.
Patients participating in other research studies.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Participants with Thyroid cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrei Iagaru	Stanford University	Principal Investigator
Iain Ross McDougall	Stanford University	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013964	Thyroid Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000614959	Iodine-124
C000614958	Iodine-123
D019788	Fluorodeoxyglucose F18

Ancestor Terms

ID	Term
D003847	Deoxyglucose
D003837	Deoxy Sugars
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided