Preoperative Planning With PSMA-PET in Melanoma Surgery Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- PSMA PET-CT detection of melanoma metastases
研究概览
简要总结
This is a non-randomised, single-centre Phase 2 study, investigating whether the diagnostic biomarker, prostate-specific membrane antigen (PSMA), can detect melanoma metastases using PSMA PET/ CT.
详细描述
Our proposed 'Preoperative Planning PSMA-PET in Melanoma Surgery (PPPIMS)' trial is a Phase 2 study, investigating the ability of PSMA as a biomarker to accurately detect melanoma metastases in patients with palpable lymphadenopathy and oligometastatic melanoma. If proven to have diagnostic utility, it may allow more precise 3D lymphatic mapping and identification of tumour in intricate anatomical areas, resulting in more accurate surgical planning. A more precise delineation of nodal disease and metastasis will result in a more accurate and lesser surgical dissection, and consequent reduction in morbidity.
We will also compare the PSMA-PET-CT with standard-of-care imaging, FDG-PET-CT to evaluate utility of this approach. It is of note that FDG-PET CT has a high background FDG uptake normally seen in the brain and liver, and PSMA could potentially be a more favourable tracer if there is less background uptake.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Males ≥18 years of age
- •Biopsy proven first and recurrent metastatic melanoma with palpable nodal disease who have undergone a staging FDG PET-CT scan as part of routine clinical care and are scheduled for surgery for resection of the primary site
排除标准
- •Patients unable to give voluntary written informed consent to participate in this study
- •Patients not willing to complete all the study assessments
- •Patients who are females
- •Patients who are taking androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists.
- •Patients who have or have previously been diagnosed with prostate cancer
- •Patients who have had Lu-177 PSMA therapy or barium studies within a period of 10 days prior to undergoing PSMA PET-CT scanning
- •Patients not fluent in English
研究组 & 干预措施
PSMA PET-CT
Within the two weeks prior to surgery, the patients will undergo both PSMA PET-CT & FDG PET-CT scans at least 48 hours apart.
The Investigational Medicinal Product (IMP) under investigation in this trial is 68Ga-PSMA. This is an imaging radionuclide tracer.
干预措施: 68Ga-PSMA (Drug)
结局指标
主要结局
PSMA PET-CT detection of melanoma metastases
时间窗: 1 Year
The principal objective of the study is to investigate whether the diagnostic biomarker, prostate-specific membrane antigen (PSMA), can detect melanoma metastases using a PSMA PET/ CT.
次要结局
- Compare FDG PET-CT & PSMA PET-CT(1 Year)