Trial Outcomes & Findings for Recombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer (NCT NCT00181168)

Results Overview

PET/CT was performed before (basal PET) and 24-48 h after rhTSH administration (rhTSH-PET) in 63 patients (52 papillary and 11 follicular thyroid cancers). Images were blindly analyzed by two readers. The proposed treatment plan was prospectively assessed before basal PET, after basal PET, and again after rhTSH-PET.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

63 participants

Primary outcome timeframe

21 Days

Results posted on

2018-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	Euthyroid Group Subjects received rhTSH to prepare for radioiodine therapy	Hypothyroid Group Thyroid hormone treatment was withheld before radioiodine therapy.
Overall Study STARTED	30	33
Overall Study COMPLETED	30	33
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Recombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Euthyroid Group n=30 Participants Adults (age \>18 years) with a history of treated well-differentiated epithelial thyroid carcinoma (papillary, follicular, or Hürthle cell), for which total or near total thyroidectomy plus postoperative radioiodine remnant ablation with 131-I has either been performed or found to be unnecessary by radioiodine imaging after TSH stimulation. Subjects received rhTSH to prepare for radioiodine therapy	Hypothyroid Group n=33 Participants Adults (age \>18 years) with a history of treated well-differentiated epithelial thyroid carcinoma (papillary, follicular, or Hürthle cell), for which total or near total thyroidectomy plus postoperative radioiodine remnant ablation with 131-I has either been performed or found to be unnecessary by radioiodine imaging after TSH stimulation. Thyroid hormone treatment was withheld before radioiodine therapy.	Total n=63 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	33 Participants n=7 Participants	63 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment France	13 participants n=5 Participants	14 participants n=7 Participants	27 participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	19 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: 21 Days

PET/CT was performed before (basal PET) and 24-48 h after rhTSH administration (rhTSH-PET) in 63 patients (52 papillary and 11 follicular thyroid cancers). Images were blindly analyzed by two readers. The proposed treatment plan was prospectively assessed before basal PET, after basal PET, and again after rhTSH-PET.

Outcome measures

Outcome measures
Measure	Euthyroid Group n=30 Participants Subjects received rhTSH to prepare for radioiodine therapy.	Hypothyroid Group n=33 Participants Thyroid hormone treatment was withheld before radioiodine therapy.
PET-CT Fusion Scanning Sensitivity	49 percentage of participants Interval 36.0 to 62.0	54 percentage of participants Interval 41.0 to 67.0

SECONDARY outcome

Timeframe: 21 Days

Outcome measures

Outcome data not reported

Adverse Events

Euthyroid Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hypothyroid Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul W. Ladenson, MD, Professor and PI

Johns Hopkins Univ

Phone: 4109553663

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place