Dosimetry Using a CZT-camera Following LUTATHERA® Therapy

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Спонсоры

Central Hospital, Nancy, France

КЛИНИЧЕСКИЕ ИСПЫТАНИЯ: NCT04467567

BioSeek: nct04467567

Ключевые слова

абстрактный

The aim of this study is to assess the consistency between a dosimetry protocol using a large field of view CZT-camera and the dosimetry protocol used for recordings acquired with a conventional camera. Therefore, with the conventional camera, recordings are acquired on the "high energy" peak of lutetium 177 (208 keV) using a medium energy collimator. With the VERITON-CT™ CZT camera, recordings are acquired using the low energy peak of 113 keV. A second objective is to compare results between the dosimetry calculated using 3 measurement points (24h, 96h and 168h) and the dosimetry calculated using 2 measurement points (24h and 168h), obtained from the SYMBIA T conventional camera and the VERITON-CT™camera, respectively.

Описание

177Lu-DOTATATE has been proven to be an effective therapy for treatment of neuroendocrine tumors. Treatment with [177Lu]-DOTA-TATE consists of 4 cycles, with an infusion of 7.4 GBq (200mCi) every 8 weeks. An imaging protocol to study dosimetry throughout the cycles is essential to determine the average dose absorbed by critical organs and by tumor lesions. The critical organs studied in association with [177Lu]-octreotate treatment are predominantly kidneys and the bone marrow. In this open-label trial, 15 patients undergoing Lutathera® treatment could be enrolled in the study. Patients will have an abdominopelvic SPECT / CT recorded using a conventional Anger camera, followed by a whole-body SPECT / CT recording using a CZT camera. Recordings will be acquired at 24 hours, 96 hours and then at 7 days after the Lutathera® infusion that is administered during one of the 4 treatment cycles. The correlation between the dosimetry results and the appearance of possible grade 3 and 4 side effects will be established.

Даты

Последняя проверка:	05/31/2020
Первый отправленный:	06/21/2020
Предполагаемая регистрация отправлена:	07/07/2020
Первое сообщение:	07/12/2020
Последнее обновление отправлено:	07/07/2020
Последнее обновление опубликовано:	07/12/2020
Фактическая дата начала исследования:	09/24/2020
Предполагаемая дата завершения начальной школы:	03/24/2022
Предполагаемая дата завершения исследования:	09/24/2022

Состояние или болезнь

Dosimetry

Вмешательство / лечение

Other: patients treated with lutathera

Фаза

Группы рук

Рука	Вмешательство / лечение
Experimental: patients treated with lutathera Patients undergoing treatment with Lutathera® and who accept to participate in the study, regardless of the cycle of treatment, 1, 2, 3 or 4.	Other: patients treated with lutathera SPECT/CT will be performed after Lutathera® treatment (at 24h, 96h and 168h after the infusion of Lutathera®) on the conventional camera and on the VERITON-CT camera

Критерии приемлемости

Возраст, имеющий право на обучение	18 Years Чтобы 18 Years
Полы, имеющие право на обучение	All
Принимает здоровых добровольцев	да
Критерии	Inclusion Criteria: - Major adult subject - ECOG ≤ 2 - Subject receiving treatment with Lutathera® - Subject having given written, free and informed consent - Affiliation to a social security scheme Exclusion Criteria: - Contraindication to treatment with Lutathera® - Subject referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code. - Pregnant woman, parturient or nursing mother. - Subject with a legal protection measure (guardianship, curatorship, safeguard of justice). - Subject unable to express consent. - Subject deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under Articles L. 3212-1 and L.3213-1

Результат

Основные показатели результатов

1. Results of the dosimetry obtained from the 2 cameras [168 hours]

Comparison between dosimetry results obtained from the conventional camera and from the VERITON-CT™ CZT camera.

Меры вторичного результата

1. Results of the dosimetry obtained from the 2 cameras when utilizing 3 points of measurement and when utilizing 2 points of measurement [24 hours, 96 hours, 168 hours]

Measurement of the average absorbed doses to sensitive organs (bone marrow and kidneys) and to tumor lesions obtained when utilizing 3 measurement points (24h, 96h and 168h) and then obtained when utilizing 2 measurement points (24h and 168h) after the administration of Lutathera®, from both a VERITON-CT™ camera and from a SYMBIA T camera.

2. Correlation between the dosimetry results [24 hours, 96 hours, 168 hours]

Average absorbed doses to the kidneys and to the bone marrow versus renal function (creatininaemia, glomerular filtration rate [GFR], blood ionogram), and versus bone marrow activity (blood count).