Pilot Study of 68Gallium PSMA-PET/CT in Patients With Metastatic Urothelial Carcinoma or Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 7
- 主要终点
- Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Urothelial Carcinoma
研究概览
简要总结
The purpose of this study is to see whether 68Gallium PSMA-PET/CT scans are an effective way to detect sites of cancer in people with metastatic bladder cancer or skin cancer. The study researchers want to learn if a 68Gallium PSMA PET/CT scan will work better, the same, or not as well as the PET/CT scans doctors usually use for imaging bladder cancer or skin cancer (FDG-PET/CT scan).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •for Urothelial Carcinoma Cohort:
- •Patients with histologically confirmed metastatic urothelial carcinoma with extrapelvic nodal and/or visceral sites of disease (including lung, liver, bone, or soft tissue)
- •At least 1 lesion assessable by FDG PET/CT according to RECIST and PERCIST guidelines where applicable, that are determined suspicious for metastasis by an MSKCC attending radiologist or nuclear medicine physician.
- •Karnofsky performance status ≥50% (or ECOG/WHO ≤2)
- •Participant is ≥18 years of age
- •Patient must be able to understand and is willing to sign a written informed consent document
- •Inclusion Criteria for Melanoma Cohort:
- •Patients with histologically confirmed metastatic melanoma
- •At least 1 metastatic lesion assessable by CT or FDG PET/CT according to RECIST that is determined to be suspicious for metastasis by an MSKCC attending radiologist or nuclear medicine physician
- •ECOG <= 2
- •Participant is >= 18 years of age
- •Patient must be able to understand and is willing to sign a written informed consent document
排除标准
- •for Urothelial Carcinoma Cohort:
- •Patients with pelvic node-only metastatic disease. If the patient has lymph node only disease, at least one PET-assessable node must be located outside of the pelvis
- •Patients with bone only disease
- •Unable to lie flat, still, or to tolerate a PET scan
- •Patient undergoing active treatment for non-urothelial malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized.
- •Patients on a therapeutic clinical trial where PSMA imaging would interfere with the conduct of the trial
- •Patients undergoing active surveillance with a known history of non-urothelial malignancies
- •Women who are pregnant. All women of childbearing potential must have a documented negative pregnancy test.
- •Exclusion Criteria for Melanoma Cohort:
- •Unable to lie flat, still, or tolerate PET scan.
- •Patient is on another therapeutic trial where PSMA imaging would interfere with the conduct of the trial.
- •Women who are pregnant. All women of childbearing potential must have a documented negative pregnancy test.
研究组 & 干预措施
Patients with melanoma lesions
Patients with melanoma who have 1 or more radiographically assessable metastatic lesions on standard of care imaging will undergo a 68Gallium PSMA-PET/CT and standard of care imaging (either FDG PET or CT scan).
干预措施: PET/CT imaging (Diagnostic Test)
Patients with metastatic urothelial carcinoma lesions
Patients will initially undergo a standard of care FDG PET with diagnostic CT scan followed by an investigational 68Ga PSMA PET/CT scan.
干预措施: PET/CT imaging (Diagnostic Test)
Patients with melanoma lesions
Patients with melanoma who have 1 or more radiographically assessable metastatic lesions on standard of care imaging will undergo a 68Gallium PSMA-PET/CT and standard of care imaging (either FDG PET or CT scan).
干预措施: [68Ga]PSMA (Drug)
Patients with metastatic urothelial carcinoma lesions
Patients will initially undergo a standard of care FDG PET with diagnostic CT scan followed by an investigational 68Ga PSMA PET/CT scan.
干预措施: [68Ga]PSMA (Drug)
结局指标
主要结局
Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Urothelial Carcinoma
时间窗: 1 year
If 6 of 10 patients have at least one lesion identified both on standard of care FDG PET/CT and also detected on 68Gallium PSMA-PET/CT, this imaging modality will be worthy of further exploration in metastatic UC.
Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Melanoma
时间窗: 1 year
If 6 of 10 patients have at least one lesion identified both on standard of care FDG PET/CT and also detected on 68Gallium PSMA-PET/CT, this imaging modality will be worthy of further exploration in metastatic Melanoma.
次要结局
未报告次要终点