Role of radio-labelled GCC-compounds in diagnosis and treatment planning of colorectal cancer

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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/11/047568

Enrollment

Registered

2022-11-23

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C189- Malignant neoplasm of colon, unspecified Health Condition 2: C19- Malignant neoplasm of rectosigmoidjunction Health Condition 3: C20- Malignant neoplasm of rectum

Interventions

Intervention1: Drugs - 68Ga-DOTA-GCC-RB and 177Lu-DOTA-GCC-RB: 68Ga-DOTA-GCC-RB will be injected intravenously at a dose of 74-148 MBq, approximately 45-60 minutes before PET/CT scan acquisition. A s

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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 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

Design outcomes

Primary

Measure	Time frame
68Ga-DOTA-GCC-RB PET/CT imaging (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

Measure	Time frame
177Lu-DOTA-GCC-RB dosimetry (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 (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	—

Measure

Time frame

177Lu-DOTA-GCC-RB dosimetry (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 (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

—

Countries

India

Contacts

Public ContactKunal Ramesh Chandekar

All India Institute of Medical Sciences, New Delhi

csbal@hotmail.com91-9013775659

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026