Optimization and Individualization of Diagnostic Scintigraphy Protocol and Minimally Invasive Radio-guided Parathyroid Surgery

University Hospital Ostrava

Status: Completed

Conditions: Primary Hyperparathyroidism; Thyroid Disease; Parathyroid Adenoma; Parathyroid Diseases

Treatments: Procedure: Multi-phase SPECT/CT; Procedure: Individualised minimally-invasive radio-guided parathyroidectomy; Procedure: Conventional (dual-phase) SPECT/CT; Procedure: Conventional minimally-invasive radio-guided parathyroidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04344886

FNO-ENT-Parathyroid_adenoma

Details and patient eligibility

About

The radio-guided technique offers both help with in-vivo identification and ex-vivo confirmation of parathyroid adenoma. In-vivo accuracy is most important but its results are not satisfactory. The aim of this study was to evaluate if there is a beneficial effect of individualized timing of surgery using preoperative multi-phase 99mTc-MIBI single-photon emission computed tomography (SPECT)/CT on in-vivo characteristics of minimally invasive radio-guided parathyroidectomy.

Full description

Despite the relatively accurate preoperative topographic information, minimally invasive parathyroid surgery can still be very challenging, especially in the case of small adenoma in ectopic localization. Radioguided technique offers both help with in-vivo identification and ex-vivo confirmation of adenoma. Excellent ex-vivo radio guidance results are referred. But, in-vivo accuracy is most important but its results are not satisfactory. The aim of this study was to evaluate if there is a beneficial effect of individualized timing of surgery using preoperative multi-phase 99mTc-MIBI single-photon emission computed tomography (SPECT)/CT on in-vivo characteristics of minimally invasive radio-guided parathyroidectomy.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients
• No history of thyroid or parathyroid surgery
• Diagnosis of primary hyperparathyroidism
• Indication for 99mTc-MIBI SPECT/CT examination

Exclusion criteria

• Minor patients
• Negative SPECT/CT findings
• Patients refusing surgery
• Previous combined surgery on the thyroid gland
• Patients in high risk of general anesthesia
• Patients who do not undergo surgery in the recommended time span

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Conventional (dual-phase) SPECT/CT

Experimental group

Description:

Adult patients with primary hyperparathyroidism undergoing conventional (dual-phase) SPECT/CT (after 10 and 150 minutes) and conventional minimally-invasive radio-guided parathyroidectomy in a time span 2-3 hours from radionuclide administration.

Treatment:

Procedure: Conventional (dual-phase) SPECT/CT

Procedure: Conventional minimally-invasive radio-guided parathyroidectomy

Multi-phase SPECT/CT

Experimental group

Description:

Adult patients with primary hyperparathyroidism undergoing multi-phase SPECT/CT (after 10, 90, 150, 210 minutes) and individualized minimally-invasive radio-guided parathyroidectomy performed in a recommended time span based on standardized uptake value calculation.

Treatment:

Procedure: Individualised minimally-invasive radio-guided parathyroidectomy

Procedure: Multi-phase SPECT/CT