EUCTR2016-002485-31-NL进行中（未招募）1 期
Optimisation of [68Ga] PSMA-11 PET/CT Imaging Protocol for localizing primary prostate cancer prior to radical prostatectomy - optimisation of PSMA PET/CT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Male aged 18 years or older
- •Ability to provide signed informed consent and willingness to comply with protocol requirements.
- •Biopsy confirmed presence of adenocarcinoma of the prostate gland
- •Planned/already executed mpMRI (standard of care).
- •Planned for radical prostatectomy (standard of care).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
- •Male aged 18 years or older
- •Ability to provide signed informed consent and willingness to comply with protocol requirements.
- •Biopsy confirmed presence of adenocarcinoma of the prostate gland
- •Planned/already executed mpMRI (standard of care).
- •Planned for radical prostatectomy (standard of care).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
- •Male aged 18 years or older
- •Ability to provide signed informed consent and willingness to comply with protocol requirements.
- •Biopsy confirmed presence of adenocarcinoma of the prostate gland
- •Planned/already executed mpMRI (standard of care).
- •Planned for radical prostatectomy (standard of care).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives, or completing the study. (part A and B)
- •Have a contraindication for mpMRI. (part A and B)
- •Will not undergo a radical prostatectomy. (part A and B)
- •Claustrophobia (part A and B)
- •Multiple malignancies (part A and B)
- •Anticoagulant therapy (part A)
- •Obese (>120 kg) (part A)
- •Have undergone a transurethral resection of prostate in the past (part A and B)
- •Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives, or completing the study. (part A and B)
- •Have a contraindication for mpMRI. (part A and B)
- •Will not undergo a radical prostatectomy. (part A and B)
- •Claustrophobia (part A and B)
- •Multiple malignancies (part A and B)
- •Anticoagulant therapy (part A)
- •Obese (>120 kg) (part A)
- •Have undergone a transurethral resection of prostate in the past (part A and B)
- •Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives, or completing the study. (part A and B)
- •Have a contraindication for mpMRI. (part A and B)
- •Will not undergo a radical prostatectomy. (part A and B)
- •Claustrophobia (part A and B)
- •Multiple malignancies (part A and B)
- •Anticoagulant therapy (part A)
- •Obese (>120 kg) (part A)
- •Have undergone a transurethral resection of prostate in the past (part A and B)
研究者
相似试验
已完成
3 期
Optimisation of [68Ga] PSMA-11 PET/CT Imaging Protocol for localizing primary prostate cancer prior to radical prostatectomyProstate cancerNL-OMON43099niversitair Medisch Centrum Groningen20
进行中（未招募）
1 期
Investigation of 68GaPSMA PET/CT as an imaging biomarker in solid tumorsadvanced/metastatic solid tumorsMedDRA version: 20.0Level: LLTClassification code 10027477Term: Metastatic carcinomaSystem Organ Class: 100000004864EUCTR2016-004376-21-ITISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS400
尚未招募
不适用
Optimisation of [68Ga] PSMA-11 PET/CT Imaging Protocol for localizing primary prostate cancer prior to radical prostatectomyNL-OMON29500niversiy Medical center Groningen (UMCG)20
进行中（未招募）
1 期
Prospective evaluation of 68Ga-PSMA PET-CT for Recurrence detection of Prostate Cancer and its impact on patient management. The ProsPERo TrialMales 18 years of age or older with histologically-proven prostate adenocarcinoma and biochemical relapse with rising PSA level after initial treatment with radical curative intent, not yet on palliative systemic treatment and considered for further salvage therapyMedDRA version: 19.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10068979Term: Imaging procedureSystem Organ Class: 10022891 - InvestigationsEUCTR2016-000842-79-BEInstitut Jules Bordet75
招募中
不适用
Non-significant Risk (NSR) Study of [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on RefleXion X1Prostate CancerNCT06353321University of Texas Southwestern Medical Center25