Imaging, biodistribution and dosimetry of the novel PET radiotracer 68Ga-DOTA-GCC-RB and Head-to-Head imaging comparison with 18F-FDG PET/CT, along with dosimetry of low dose 177Lu-DOTA-GCC-RB in Patients with Colorectal Carcinoma: A Phase I Pilot study

All India Institute of Medical Sciences, New Delhi0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年1月9日

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•1. Histologically proven colorectal carcinoma
•2. Patients who have undergone 18F-FDG PET/CT for staging/re-staging within the last 2 weeks
•3. For women of childbearing potential (WOCBP), highly effective contraceptive use during study participation and for 7 months following the last administration of 177Lu-DOTA-GCC-RB.
•4. Sexually active male subjects whose sexual partners are WOCBP must agree to use a highly effective method of contraception for 4 months following receipt of 177Lu-DOTA-GCC-RB.

•1. Pregnant and lactating females
•2. Patients who refuse to give written informed consent
•3. Recent anti-cancer chemotherapy/surgery in less than four weeks or radiotherapy in less than eight weeks
•4. Known inflammatory bowel disease
•5. Unable to give informed consent or withdrawal of consent any point of time
•6. Eastern Cooperative Oncology Group (ECOG) performance status >= 3
•7. Renal impairment demonstrated by CrCl <30ml/hr
•8. Concurrent primary malignancy other than colorectal cancer, except adequately treated carcinoma in situ, non-melanoma carcinoma of the skin or any other curatively treated malignancy that has achieved complete response and is not expected to require treatment for recurrence during participation in the study
•9. Subjects with known allergies against any ingredient of the investigational medicinal product (IMP)
•10. Active serious infection not controlled by antibiotics

发起方

All India Institute of Medical Sciences, New Delhi