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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Molecular Imaging

Intervention / Treatment
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* Radiation: 68Ga-NODAGA-ZIGF-1R:4：40


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Colon cancer, NSCLC and gliomas patients with pathological and gene detection results and did not receive any treatment More than 18 years old A life expectancy of at least 12 weeks Presence of a malignant lesion within the chest of at least 0.5 cm diameter as measured by computed tomography (CT) Written informed consent Exclusion Criteria: Could not get pathological and gene detection results Pregnancy do not want to write informed consent。

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-NODAGA-ZIGF-1R:4：40：IGF-1R+++<br>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<br>* No Intervention<br>|
| Experimental: 68Ga-NODAGA-ZIGF-1R:4：40：IGF-1R++<br>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<br>* No Intervention<br>|
| Experimental: 68Ga-NODAGA-ZIGF-1R:4：40：IGF-1R+<br>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<br>* No Intervention<br>|
| Experimental: 68Ga-NODAGA-ZIGF-1R:4：40：healthy volunteers<br>Patients in this group who are healthy volunteer. | Radiation: 68Ga-NODAGA-ZIGF-1R:4：40<br>* No Intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |