NCT01837745 - Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients? | Biotech Hunter

Enrollment

776

Participants

Timeline

Start Date

May 13, 2013

Primary Completion Date

April 1, 2022

Study Completion Date

January 1, 2030

Conditions

Low Risk Differentiated Thyroid Cancer

Interventions

DRUG

rhTSH stimulation

Intramuscular injections of rhTSH (0.9 mg) on two consecutive days on LT4 treatment

DRUG

I131

An activity of 1.1 GBq of I131 is given orally 24 hours after the second injection of rhTSH.

OTHER

Follow up

"* 10 (+/- 2 months) after randomization: a neck ultrasound and a serum Tg measurement after rhTSH or LT4 stimulation~* 2 years (+/- 2 months) after randomization: a serum Tg measurement under LT4 treatment (Tg/LT4)~* 3 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4~* 4 years (+/- 2 months) after randomization: a serum Tg/LT4~* 5 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4~* 8 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4~* 10 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4~* 12 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4"

Trial Locations (1)

94805

Institut Gustave Roussy, Villejuif

All Listed Sponsors

lead

Gustave Roussy, Cancer Campus, Grand Paris

OTHER