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

Molecular Imaging Clinical Trial

Official title:

Targeted Molecular Imaging of [68Ga]- Labelling Anti-IGF-1R Affibody Molecule in IGF-1R Overexpression Cancer Patients （Such as Colon Cancer、NSCLC and Gliomas）and Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02916394
• Other study ID #: 14403
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2020
• Source: Harbin Medical University
• Contact: Yingying Sun
• Phone: 18846797135
• Email: 505679386[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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?

Related Conditions & MeSH terms

• Molecular Imaging

Intervention

Radiation:
• 68Ga-NODAGA-ZIGF-1R:4:40
No Intervention

Locations

Country	Name	City	State
China	TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor SUV value of 68Ga-NODAGA-ZIGF-1R:4:40 PET/CT 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.	after scanning(at time of imaging)