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

February 20, 2020 updated by: Yingying Sun, Harbin Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150028
        • Recruiting
        • TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-NODAGA-ZIGF-1R:4：40：IGF-1R+++
Patients in this group had IGF-1R overexpression tumors and did not receive any treatment before this study.
Radiation: 68Ga-NODAGA-ZIGF-1R:4：40
No Intervention
Experimental: 68Ga-NODAGA-ZIGF-1R:4：40：IGF-1R++
Patients in this group had IGF-1R moderate expression tumors and did not receive any treatment before this study.
Radiation: 68Ga-NODAGA-ZIGF-1R:4：40
No Intervention
Experimental: 68Ga-NODAGA-ZIGF-1R:4：40：IGF-1R+
Patients in this group had IGF-1R low expression tumors and did not receive any treatment before this study.
Radiation: 68Ga-NODAGA-ZIGF-1R:4：40
No Intervention
Experimental: 68Ga-NODAGA-ZIGF-1R:4：40：healthy volunteers
Patients in this group who are healthy volunteer.
Radiation: 68Ga-NODAGA-ZIGF-1R:4：40
No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor SUV value of 68Ga-NODAGA-ZIGF-1R:4:40 PET/CT Imaging
Time Frame: 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.
after scanning(at time of imaging)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harbin Medical University

Investigators

  • Study Chair: Baozhong Shen, The Fourth Hospital of Harbin Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

September 24, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (Estimate)

September 27, 2016

Study Record Updates

Last Update Posted (Actual)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 14403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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