Only patiens MedDRA version: 14.1 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Name: NA
Product Code: NA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: I124
CAS Number: NA
Current Sponsor code: Iodio
Other descriptive name: NA
Concentration unit: MBq me
Sponsors
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed