Therapy with high activity of radioiodine in patients bearing differentiated thyroid cancer

Differentiated thyroid cancer: metabolic radiotherapy with high activity of radioiodine calculated by individual pre-therapy dosimetry - High activity of radioiodine

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005248-81-IT

Enrollment

Registered

2011-12-28

Start date

2012-01-31

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Patients bearing differentiated thyroid carcinoma with distant metastases, candidated to metabolic radiotherapy after surgery or repetition of same therapy MedDRA version: 14.1 Level: PT Classification code 10055107 Term: Thyroid cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: iodine-131 Pharmaceutical Form: Capsule INN or Proposed INN: IODINE (131I) SODIUM CAS Number: 7790-26-3 Concentration unit: mCi millicurie(s) Concentration type: not less then Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - diagnosis of differentiated thyroid carcinoma - ECOG performance status of grade 0 or 1 - Age between 18 and 80 years old - Life expectancy of 3 months at least - Fertile women compliance to adopt contraceptive methods for at least 6 months after treatment -Adequate medullar reserve and renal functionality - Eventual second tumor in complete remission for 5 years at least - 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Presence of serious concomitant non neoplastic diseases, not adequately controlled - Pregnancy or breast feeding - Impossibility to follow-up - Concomitant use of nephrotoxic drugs - Surgery or radiotherapy within 2 weeks from beginning of treatment - Pulmonary diffused micrometastases - Extensive skeletal metastases

Design outcomes

Primary

Measure	Time frame
Main Objective: main objective of the study is the feasibility, the toxicity and the therapeutic efficacy of the treatment with elevated activities of radioiodine respect the scheme with fixed activities.;Secondary Objective: There aren't secondary objectives;Primary end point(s): Evaluation of the therapeutic efficacy of the treatment with elevated activities;Timepoint(s) of evaluation of this end point: Clinical response is evaluated 6 months after treatment	—

Measure

Time frame

Main Objective: main objective of the study is the feasibility, the toxicity and the therapeutic efficacy of the treatment with elevated activities of radioiodine respect the scheme with fixed activities.;Secondary Objective: There aren't secondary objectives;Primary end point(s): Evaluation of the therapeutic efficacy of the treatment with elevated activities;Timepoint(s) of evaluation of this end point: Clinical response is evaluated 6 months after treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Evaluation of the feasibility of the pre-therapy dosimetry for the calculation of the administrable activity;Timepoint(s) of evaluation of this end point: During protocol	—

Countries

Italy

Contacts

Public ContactMedicina Nucleare

Fondazione IRCCS Istituto Nazionale dei Tumori

ettore.seregni@istitutotumori.mi.it02 23902688

Outcome results

None listed

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