Study for metastatic thyroid cancer using 124i and [18F] FDG PET / CT in patients with elevated values of Tg and / or AbTg with negative ultrasonography of the neck, previously treated with thyroidectomy and radioiodine therapy. - I124

Conditions: Only patiens
MedDRA version: 14.1Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - Investigations
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2010-023831-40-IT

Lead Sponsor: FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients with elevated values of Tg and / or Tg Ab who previously underwent total thyroidectomy and subsequent radioiodine therapy in which the ultrasound of the neck was negative.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Diabetic patients
Patients undergoing investigations with iodinated contrast material in the previous three months.
Patients previously treated with amiodarone hydrochloride.
Women who are pregnant or breastfeeding
Age <18 years

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): I124 test the efficacy of PET / CT in the detection of recurrence.;Main Objective: 124i and [18F] FDG PET / CT identification of repetitive lesions responsible for raising the Tg values and / or AbTg in patients undergoing total thyroidectomy and subsequent radioiodine therapy with negative ultrasound of the neck;Secondary Objective: To correlate the different types of uptakes, 124i or [18F] FDG, with the different oncogenic profiles shown in primary tumors and, where possible, with the profiles of the oncogenic metastases.

Secondary Outcome Measures