Role of radio-labelled GCC-compounds in diagnosis and treatment planning of colorectal cancer
- Conditions
- Health Condition 1: C189- Malignant neoplasm of colon, unspecifiedHealth Condition 2: C19- Malignant neoplasm of rectosigmoidjunctionHealth Condition 3: C20- Malignant neoplasm of rectum
- Registration Number
- CTRI/2022/11/047568
- Lead Sponsor
- All India Institute of Medical Sciences, New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 68Ga-DOTA-GCC-RB PET/CT imaging <br/ ><br> <br/ ><br>(Assessment of 68Ga-DOTA-GCC-RB PET/CT imaging to detect lesions in patients with colorectal carcinoma)Timepoint: 45 minutes to 1 hour from time of injection
- Secondary Outcome Measures
Name Time Method 177Lu-DOTA-GCC-RB dosimetry <br/ ><br> <br/ ><br>(Assessment of organ dosimetry of 177Lu-DOTA-GCC-RB using SPECT/CT imaging at various time points in a subset of five patients with colorectal carcinoma)Timepoint: 1-7 days from time of injection;68Ga-DOTA-GCC-RB dosimetry <br/ ><br> <br/ ><br>(Assessment of organ dosimetry of 68Ga-DOTA-GCC-RB using PET/CT imaging at various time points in a subset of three patients with colorectal carcinoma)Timepoint: 1-7 days from time of injection