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临床试验/ISRCTN71215418
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

发起方
ImaginAb (United States)

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