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临床试验/NCT03576040
NCT03576040已完成不适用

Prognostic Interest of a Whole Body Dynamic PET Acquisition in Pre-therapeutic 68Ga-DOTATOC PET/CT for Neuroendocrine Tumors

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Recidive free survival (RFS)

研究概览

简要总结

Neuroendocrine tumors (NET) are a network of rare tumors with common embryological origin. Functional imaging plays a major role in the extension assessment and tumor characterization of NETs. SPECT/CT with 111In-pentetreotide is the recommended test when tumors are well differentiated (grade G1 or G2). It has a real interest in diagnosis, in therapeutic decision-making (in particular by cold somatostatin analogues or in PRRT) and in the systematic follow-up of patients. Nevertheless, SPECT/CT procedure makes for a relatively long review. In addition, scintigraphy has a lower spatial resolution than PET technology and remains of limited interest for signal quantification.

However, the ability to locate and quantitatively measure the absorption of radiopharmaceuticals in the target tissues is a major challenge in oncology for the characterization of the disease.

Recent developments in radiopharmacy have made it possible to target NETs in PET imaging through the use of somatostatin analogues coupled with positron emitters, called 68Ga-DOTA peptides. The diagnostic performance of 68Ga-DOTApeptide PET/CT appears to be superior to SPECT/CT with 111In-pentetreotide. A marketing authorization has thus recently been issued in France for the use of 68Ga-DOTATOC.

Historically, the recommended quantification method in PET was based on the instantaneous measurement in static acquisition (3D) of the maximum of the standardized uptake value (SUVmax). This approach has the disadvantage to measure the signal at a time "t" for a single voxel of the image. Dynamic acquisition methods (4D) have been proposed to extract a radiotracer absorption coefficient (Ki) for a lesion. Several studies have demonstrated the superiority of Ki versus SUVmax in 18FDG PET/CT for the diagnostic management, therapeutic evaluation and prognosis of various solid cancers.

However, no work has validated this approach in PET / CT at 68Ga-DOTATOC as part of the prognostic evaluation of NETs.

The objective of the study is to evaluate the prognostic value of the tumor absorption coefficient Ki resulting from a 4D whole-body dynamic acquisition in PET / CT at 68Ga-DOTATOC in patients with well-differentiated NETs grade I or II according to the WHO classification

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient majeur ≥ 18 year old
  • Présenting a well differentiated neuroendocrine tumor (G1 ou G2)
  • Indication performing a68Ga-DOTATOC PET/CT
  • non-opposition

排除标准

  • Patient <18 years old
  • Breastfeeding/ pregnancy
  • Other type of tumor
  • Refusal of participation

结局指标

主要结局

Recidive free survival (RFS)

时间窗: 2 years

To evaluate the prognostic value of Ki lesion on progression-free survival at 2 years and compare it with SUVmax (static 3D acquisition) in patients with localised well-differentiated NET

Progression free survival (PFS)

时间窗: 2 years

To evaluate the prognostic value of lesionnal Ki on progression-free survival at 2 years and compare it with SUVmax (static 3D acquisition) in patients with metastatic well-differentiated NET

次要结局

  • Predictive value of non-event survival (PFS+RFS)(6 months to 2 years)
  • Correlation between 68Ga-DOTATOC PET/CT and/or 111In-pentetréotide SPECT/CT and 177Lu-DOTATATE SPECT/CT(0 to 2 years)
  • Correlation between lesionnal Ki and immunochemistry markers(0 to 2 years)
  • Prognostic value of Ki versus usual prognostic parameters(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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