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

Harbin Medical University

Status: Unknown

Conditions: Molecular Imaging

Treatments: Radiation: 68Ga-NODAGA-ZIGF-1R:4：40

Study type: Interventional

Funder types: Other

Identifiers

NCT02916394

14403

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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。

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 4 patient groups

68Ga-NODAGA-ZIGF-1R:4：40：IGF-1R+++

Experimental group

Description:

Patients in this group had IGF-1R overexpression tumors and did not receive any treatment before this study.

Treatment:

Radiation: 68Ga-NODAGA-ZIGF-1R:4：40

68Ga-NODAGA-ZIGF-1R:4：40：IGF-1R++

Experimental group

Description:

Patients in this group had IGF-1R moderate expression tumors and did not receive any treatment before this study.

Treatment:

Radiation: 68Ga-NODAGA-ZIGF-1R:4：40

68Ga-NODAGA-ZIGF-1R:4：40：IGF-1R+

Experimental group

Description:

Patients in this group had IGF-1R low expression tumors and did not receive any treatment before this study.

Treatment:

Radiation: 68Ga-NODAGA-ZIGF-1R:4：40

68Ga-NODAGA-ZIGF-1R:4：40：healthy volunteers

Experimental group

Description:

Patients in this group who are healthy volunteer.

Treatment:

Radiation: 68Ga-NODAGA-ZIGF-1R:4：40