Biodistribution, Tumor Detection, and Radiation Dosimentry of [18F]-AZAFOL as POSITRON EMISSION TOMOGRAPHY (PET) Tracer in Folate Receptor Positive Cancer Imaging
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- SUV values and volume of tracer uptake of all suspected positive lesions
研究概览
简要总结
This is a clinical trial category C as this is a first in man trial with an unapproved investigational product. Nevertheless the risk is considered low due to the low dose ≤ 10μg. No toxicity effects were observed preclinically at a dose >1000 -fold the intended dose. Open-labeled, non-blinded, non-placebo controlled, multicenter study.
Primary objective:
Assessment of biodistribution and FR-specific tumor detection of [18F]- AzaFol as a PET imaging agent in patients with FR-positive and FR-negative metastatic cancer of the ovaries or lungs.
Secondary objective:
Calculation of the effective dose to the patient according to the tissue distribution data of [18F]-AzaFol (Dosimetry)
详细描述
Human research study using a radiopharmaceutical product to reveal folate receptor (FR) expression in tumors in patients.
It is known that the FR is overexpressed on a variety of tumor types. FR-positive tumors can be treated with investigational drugs specifically targeting the FR.
Although the FR-expression status may be determined by immunohistochemical staining of tumor biopsies there is a need for a non-invasive method to determine the presence of the FR on primary tumors and metastases in humans. For this purpose a radiopharmaceutical product will be used as a radiotracer. Positron Emission Tomography (PET) is an imaging method which allows assessing the distribution of radiotracers (called PET tracer). With this imaging method it is possible to obtain (semi)quantitative measures of FR-expression on tumors of at least 4-10 mm diameter in patients.
Such a folate-based radiotracer would be a very helpful tool to non-invasively discriminate FR-positive (often found in ovarian and NSC-lung cancer) from FR-negative tumors in patients with cancer disease as this would allow selecting FR-positive patients amenable to FR-targeted therapies, e.g. folate-targeted antimitotic substances such as EC145 VintafolideTM (Endocyte Inc.) or anti-FR-antibodies such as FarletuzumabTM (Morphotek Inc).
Moreover, [18F]-AzaFol PET could be used for tumor staging and monitoring therapy as well as for follow-up investigations of patients with FR-positive tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cancer of the ovaries (adenocarcinoma) or non-small cell lung cancer (adenocarcinoma, squameous cell cancer or other histology) having active tumor with an indication for a systemic treatment in first or further line.
- •Last systemic treatment should not applied within 3 weeks before performing study exam
- •Male and female patients 18 years and older,
- •Voluntarily signed Informed Consent after being informed
- •Inclusion criteria for [18F]-AzaFol PET (enrollment into study):
- •FR-positive histology in routinely acquired biopsy samples (30 Patients)
- •FR-negative histology in routinely acquired biopsy samples (6 Patients)
排除标准
- •contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
- •women who are pregnant or breast feeding,
- •women with the intention to become pregnant during the course of the study,
- •other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease),
- •Renal clearance < 60 mL/min; liver transaminases ≥ 3-fold increased; bilirubin > 1.5-fold increased; Hb < 8 g/dl; Tc < 100'000, ANC < 1'500/ul
- •known or suspected non-compliance, drug or alcohol abuse,
- •inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the subject,
- •Participation in another study with an investigational drug during the present study and 7 days thereafter.
- •Enrolment of the investigator, his family members, employees and other dependent persons
研究组 & 干预措施
treatment group
all patients successfully enrolled will be assigned to the treatment group:
1 mg folic acid (corresponding to 0.2 mL Folarell®) will be injected 5 min prior to [18F]-AzaFol
干预措施: [18F]-AzaFol (Drug)
treatment group
all patients successfully enrolled will be assigned to the treatment group:
1 mg folic acid (corresponding to 0.2 mL Folarell®) will be injected 5 min prior to [18F]-AzaFol
干预措施: folarell (Drug)
结局指标
主要结局
SUV values and volume of tracer uptake of all suspected positive lesions
时间窗: day 0
SUVmax g/ml SUVmean42% g/ml lesion seen on SOC : mm
Available biopsy results can be used as further variables to better assess the performance of [18F]-AzaFol
时间窗: day 0
+ / - ( positive or negative)
Potential change of overall staging
时间窗: day 0
TNM staging
Estimation of gained information using this tracer
时间窗: day 0
uptake yes / no
General estimation of gained confidence in changing/adapting therapy based on this image
时间窗: day 0
continuous % variable of confidence
Lesion detection rate in comparison to SOC (CT and/or MR and/or FDG performed within 4 weeks of PET imaging).
时间窗: day 0
% (percentage)
quantitative estimations
时间窗: day 0
SUV values for ROC analysis g/ml
次要结局
- Calculation of the effective dose to the patient according to the tissue distribution data of [18F]-AzaFol (Dosimetry)(day 0)
研究者
Niklaus Schaefer
clinical professor
University of Lausanne Hospitals