Upfront F18-choline PET/CT versus Tc99m-sestaMIBI SPECT/CT guided surgery in primary hyperparathyroidism: the randomized phase III diagnostic trial APACH2

Autor: Stéphane Bardet, Vianney Bastit, Renaud Ciappuccini, Elske Quak, Célia Berchi, Jean-Michel Grellard, Véronique Le Henaff, Bénédicte Clarisse, Cyril Jaudet, Gauthier Foucras, Barbara Lireux, Justine Lequesne, Charline Lasnon, Audrey Lasne Cardon
Přispěvatelé: Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU), Unité de recherche interdisciplinaire pour la prévention et le traitement des cancers (ANTICIPE), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-UNICANCER, Université de Caen Normandie (UNICAEN), Normandie Université (NU), Malbec, Odile
Rok vydání: 2021
Předmět:
Male
Fluorine Radioisotopes
[SDV]Life Sciences [q-bio]
Endocrinology
Diabetes and Metabolism
lcsh:Diseases of the endocrine glands. Clinical endocrinology
Tc99m Sestamibi
030218 nuclear medicine & medical imaging
Study Protocol
0302 clinical medicine
Positron Emission Tomography Computed Tomography
F18-choline PET/CT
Clinical endpoint
Multicenter Studies as Topic
Randomized Controlled Trials as Topic
Parathyroid adenoma
Aged
80 and over
Diagnostic Trial
General Medicine
Middle Aged
Choline pet ct
Hyperparathyroidism
Primary
Prognosis
3. Good health
[SDV] Life Sciences [q-bio]
Surgery
Computer-Assisted
030220 oncology & carcinogenesis
Female
Adult
Technetium Tc 99m Sestamibi
medicine.medical_specialty
Adolescent
Primary hyperparathyroidism
Young Adult
03 medical and health sciences
Minimally invasive surgery
medicine
Humans
In patient
Aged
Tomography
Emission-Computed
Single-Photon
lcsh:RC648-665
business.industry
medicine.disease
Surgery
Clinical Trials
Phase III as Topic
MIBI SPECT/CT
Medico-economic evaluation
Radiopharmaceuticals
Complication
business
Follow-Up Studies
Zdroj: BMC Endocrine Disorders
BMC Endocrine Disorders, BioMed Central, 2021, 21 (1), pp.3. ⟨10.1186/s12902-020-00667-5⟩
BMC Endocrine Disorders, Vol 21, Iss 1, Pp 1-7 (2021)
ISSN: 1472-6823
DOI: 10.1186/s12902-020-00667-5
Popis: Background The common endocrine disorder primary hyperparathyroidism (PHPT) can be cured by surgery. Preoperative localization of parathyroid adenoma (PTA) by imaging is a prerequisite for outpatient minimally invasive parathyroidectomy (MIP). Compared to inpatient bilateral cervical exploration (BCE) which is performed if imaging is inconclusive, MIP is superior in terms of cure and complication rates and less costly. The imaging procedure F18-choline (FCH) PET/CT outperforms Tc99m-sestaMIBI (MIBI) SPECT/CT for PTA localization, but it is much costlier. The aim of this study is to identify the most efficient first-line imaging modality for optimal patient care in PHPT without added cost to society. Methods We will conduct a multicenter open diagnostic intervention randomized phase III trial comparing two diagnostic strategies in patients with PHPT: upfront FCH PET/CT versus MIBI SPECT/CT. The primary endpoint is the proportion of patients in whom the first-line imaging method results in successful MIP and cure. Follow-up including biological tests will be performed 1 and 6 months after surgery. The main secondary endpoint is the social cost of both strategies. Other secondary endpoints are as follows: FCH PET/CT and MIBI SPECT/CT diagnostic performance, performance of surgical procedure and complication rate, FCH PET/CT inter- and intra-observer variability and optimization of FCH PET/CT procedure. Fifty-eight patients will be enrolled and randomized 1:1. Discussion FCH PET/CT is a highly efficient but expensive imaging test for preoperative PTA localization and costs three to four times more than MIBI SPECT/CT. Whether FCH PET/CT improves patient outcomes compared to the reference standard MIBI SPECT/CT is unknown. To justify its added cost, FCH PET/CT-guided parathyroid surgery should lead to improved patient management, resulting in higher cure rates and fewer BCEs and surgical complications. In the previous phase II APACH1 study, we showed that second-line FCH PET/CT led to a cure in 88% of patients with negative or inconclusive MIBI SPECT/CT. BCE could be avoided in 75% of patients and surgical complication rates were low. We therefore hypothesize that upfront FCH PET/CT would improve patient care in PHPT and that the reduction in clinical costs would offset the increase in imaging costs. Trial registration NCT04040946, registered August 1, 2019. Protocol version Version 2.1 dated from 2020/04/23.
Databáze: OpenAIRE
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