Comparison of 4DCT and 18F-flurocholine to determine the culprit gland in patients of parathyroid adenoma: A pilot randomised controlled trial.

Not Applicable

• Conditions: Health Condition 1: E210- Primary hyperparathyroidism

• Registration Number: CTRI/2022/04/042050
• Lead Sponsor: Council of Scientific and Industrial Research CSIR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Biochemical evidence of primary hyperparathyroidism i.e. elevated intact parathormone (iPTH) (defined as serum iPTH > 65pg/ml) or inappropriately normal iPTH levels in the setting of hypercalcemia (defined as serum calcium > 10.5 mg/dl) and low serum phosphorus (defined as serum phosphate <2.5 mg/dl).

2.Age 18 years and above.

3.Women at child bearing age with negative pregnancy test.

4.Written consent given for inclusion in the study.

Exclusion Criteria

1.Patients of hyperparathyroidism with renal dysfunction

2.History of chronic renal disease.

3.Pregnant and/or lactating women.

4.Patients with head and neck malignancies, tuberculosis and other granulomatous diseases where the possibility of mimicking lymph nodes can arise.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with successful parathyroidectomy as determined by decline in iPTH by â?¥50%, normalized serum calcium postoperatively and histopathology suggestive of parathyroid adenoma.Timepoint: Immediately after surgery and 6-months after surgery

Secondary Outcome Measures

Name	Time	Method
1.Proportion of patients with definite preoperative localization in both the groups. <br/ ><br>2.Duration of parathyroidectomy in patients undergoing 4D-CT versus 18F-FCH-PET/CT from time of incision to the excision of gland. <br/ ><br>3.Sensitivity, specificity, positive and negative predictive value of 4D-CT versus 18F-FCH/ PET/CT with histopathology as gold standard. <br/ ><br>4.Preoperative localization of parathyroid adenoma with 4D-CT versus 18F-FCH PET/CT among patients failing detection with USG and MIBI-Scan. <br/ ><br>5.Proportion of patients with successful parathyroidectomy among subgroup of patients failing detection with USG and MIBI-Scan undergoing 4D-CT versus 18F-FCH PET/CT. <br/ ><br>6.Follow the patients for cure after 6-months of surgery in both the groups by serum calcium and iPTH. <br/ ><br>Timepoint: The study proposes a follow-up at 6 months after surgery