ISRCTN71215418已完成3 期
Positron emission tomography Repeatability Evaluation of Tissue Zirconium 89ZR CrEfmirLimab berdoxam uptake (PRETZCEL)
ImaginAb (United States)0 个研究点目标入组 12 人开始时间: 2022年10月3日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •All participants:
- •1. Aged =18 years
- •2. =1 imageable primary or metastatic lesion =1 cm in the lymph nodes or soft tissue excluding bone on the most recent standard of care imaging done within the last 3 months
- •3. Agree to follow contraceptive advice while on study until 33 days after ending participation
- •1. Melanoma on single or multiple agent Immune Checkpoint Blockade (ICB) therapy with stable response status following initiation of therapy
- •2. Stable disease observed over =2 consecutive standard of care CT scans (usually done 8-12 weeks apart) after initiation of therapy
- •1. Untreated renal cell carcinoma on active surveillance
排除标准
- •1. Uncontrolled infection or other concurrent malignancies or conditions that may confound interpretation of the scans in the opinion of the study doctor
- •2. Urinary catheters or stoma bags
- •3. Patients who have received a COVID vaccine can be included in the study but can only be scanned after a washout period of 2 weeks after the vaccine. If patients have a COVID vaccine after the first PET-CT scan, the second PET-CT scan will be delayed for =2 weeks after the COVID vaccine.
- •4. Taking steroids, except those on replacement dose of steroids for adrenal or pituitary insufficiency. Patients requiring steroids as therapy for an unresolved immune therapy related adverse event will be excluded.
- •5. Taking immunosuppressive medication e.g. cyclosporine, azathioprine, or janus kinase inhibitors
- •6. Enrolled in another therapeutic intervention study
- •7. Any other contraindication that makes the patient unsuitable to take part in the study in the opinion of the investigator
- •8. Women of child bearing potential who are pregnant or breastfeeding on study entry
- •9. Unable to provide informed consent
研究者
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