NCT07453225

Brief Summary

The aim of the study is assessment the efficacy of empiric RAI therapy in DTC patients with elevated thyroglobulin levels and negative iodine scintigraphy.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
25mo left

Started Apr 2026

Typical duration for phase_1

Status
not yet recruiting

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

Study Progress6%
Apr 2026Jul 2028

First Submitted

Initial submission to the registry

February 25, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

February 25, 2026

Last Update Submit

February 27, 2026

Conditions

Differentiated Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

  • efficacy of empirical radioactive iodine therapy

    by assessment of tumor marker (serum thyroglobulin ) if decreased after empirical therapy

    2 years

Study Arms (2)

patients received empirical dose of RAI

EXPERIMENTAL

patients treated with empirical dose

Drug: Radioactive Iodine Therapy

patients didn't receive empirical dose of RAI

NO INTERVENTION

patients monitored without empirical RAI dose

Interventions

Radioactive Iodine TherapyDRUG

empirical dose of RAI

patients received empirical dose of RAI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • This study will include adult patients with pathologically proved DTC who underwent total thyroidectomy and received RAI therapy presented to our nuclear medicine unit with evidence of persistent or recurrent biochemical disease during follow up.

You may not qualify if:

  • Undifferentiated thyroid cancer.
  • Patients with evidence of structural disease.
  • Patients less than 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Mona Nabil Helbawi

CONTACT

01097040135monahelbawi561@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Masking Description
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Model Description
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 5, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

March 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share