Role of PET/CT with 124I for dosimetry of thyroid carcinoma before radioisotopic treatment

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001386-41-IT

Enrollment

Registered

2011-12-27

Start date

2011-06-15

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

thyroid carcinoma MedDRA version: 14.1 Level: LLT Classification code 10043655 Term: Thryoid neoplasia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: Sodium Iodide I-124 Product Code: Na 124-I Pharmaceutical Form: Solution for injection INN or Proposed INN: Sodium Iodide I-124 Current Sponsor code: Sodium Iodide I-124 Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patients with diagnosis of thyroid carcinoma, already operated by radical tyroidectomy, with lung or bone metastases showing radioiodine uptake; those patients are treated with radiomethabolic therapy using 131I ? age superior or egual to 18years ? male and female ? signed informed consent 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: ? pregnancy ? breastfeeding ? patients in emergency situations ? patients of unsound mind

Design outcomes

Primary

Measure	Time frame
Main Objective: ?Main objective of the study is to evaluate the role of PET/CT with 124I for calculating an individual dose before treatment in patients affected by thyroid carcinoma; all cases are scheduled for radiomethabolic treatment with 131I as standard of care;Secondary Objective: ?Secondary objective is to evaluate the difference between dose calculated using kinetic curves of 124I as compared to doses estimated with ICRP tables;Primary end point(s): ?Difference between clinical outcomes (response to treatment and disease free survival) in the experimental group (patients treated with dose individually calculated using 124I) as compared to the control group (retrospective: data obtained from files of patients treated with estimated dose using ICRP tables);Timepoint(s) of evaluation of this end point: 6 months after the single dose of Na 124-I.	—

Measure

Time frame

Main Objective: ?Main objective of the study is to evaluate the role of PET/CT with 124I for calculating an individual dose before treatment in patients affected by thyroid carcinoma; all cases are scheduled for radiomethabolic treatment with 131I as standard of care;Secondary Objective: ?Secondary objective is to evaluate the difference between dose calculated using kinetic curves of 124I as compared to doses estimated with ICRP tables;Primary end point(s): ?Difference between clinical outcomes (response to treatment and disease free survival) in the experimental group (patients treated with dose individually calculated using 124I) as compared to the control group (retrospective: data obtained from files of patients treated with estimated dose using ICRP tables);Timepoint(s) of evaluation of this end point: 6 months after the single dose of Na 124-I.

—

Secondary

Measure	Time frame
Secondary end point(s): ? Difference between individual dose as calculated with kinetic curves of 124I and dose as estimated with ICRP tables;Timepoint(s) of evaluation of this end point: Time between Na 124-I somministration and start of treatment with 131-I.	—

Countries

Italy

Contacts

Public ContactStefano Fanti

AOU di Bologna, Policlinico S.Orsola-Malpighi

stefano.fanti@aosp.bo.it051/6363957

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026