In Vivo IGF-1R Molecular Imaging Using [68Ga]- Labelling Anti-IGF-1R Affibody Molecule

Not Applicable

• Conditions: Molecular Imaging

• Registration Number: NCT02916394
• Lead Sponsor: Harbin Medical University

Brief Summary

The investigators developed \[68Ga\]-labelling Anti-IGF-1R Affibody Molecule as a targeted molecular imaging agent for noninvasive and repeatable detecting IGF-1R expression status.

Detailed Description

The goals of investigators are to evaluate the use of \[68Ga\]-labelling Anti-IGF-1R Affibody Molecule as a novel PET/CT radiotracer to monitor IGF-1R expression status. The investigators want to evaluate the use of \[68Ga\]-labelling Anti-IGF-1R Affibody Molecule in IGF-1R expression cancer imaging in adult cancer patients （colon cancer 、NSCLC、gliomas cancer patients）with different IGF-1R expression status.

Study Timeline

• Study First Submitted: 2016-09-24
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-27
• Study Start: 2018-09-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-21
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Colon cancer, NSCLC and gliomas patients with pathological and gene detection results and did not receive any treatment
2. More than 18 years old
3. A life expectancy of at least 12 weeks
4. Presence of a malignant lesion within the chest of at least 0.5 cm diameter as measured by computed tomography (CT)
5. Written informed consent

Exclusion Criteria

1. Could not get pathological and gene detection results
2. Pregnancy
3. do not want to write informed consent。

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
tumor SUV value of 68Ga-NODAGA-ZIGF-1R:4:40 PET/CT Imaging	after scanning(at time of imaging)	To quantify the accumulation, a volume of interest using a 3D sphere, was placed over the tumor, lymph nodes and distant metastases avoiding necrosis, blood vessels and normal tissues as much as possible on a workstation (Advantage Workstation 4.6; GE Healthcare). The maximum standard uptake value (SUVmax) normalized to body weight (kBq/mL) was calculated within the region of interest.

Trial Locations

Locations (1)

TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China