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

NCT ID: NCT02916394

Last Updated: 2020-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-12-31

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.

Conditions

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Molecular Imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type RADIATION

No Intervention

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.

Group Type EXPERIMENTAL

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

Intervention Type RADIATION

No Intervention

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.

Group Type EXPERIMENTAL

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

Intervention Type RADIATION

No Intervention

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

Patients in this group who are healthy volunteer.

Group Type EXPERIMENTAL

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

Intervention Type RADIATION

No Intervention

Interventions

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

No Intervention

Intervention Type RADIATION

Eligibility Criteria

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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。
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Harbin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yingying Sun

Chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Baozhong Shen

Role: STUDY_CHAIR

The Fourth Hospital of Harbin Medical University

Locations

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TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yingying Sun

Role: CONTACT

18846797135

Facility Contacts

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Xilin Sun, M.D.

Role: primary

86-15904601908

Kai Wang, M.D.

Role: backup

86-13796601005

Other Identifiers

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14403

Identifier Type: -

Identifier Source: org_study_id

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