In Vivo IGF-1R Molecular Imaging Using [68Ga]- Labelling Anti-IGF-1R Affibody Molecule
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
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2016
CompletedFirst Posted
Study publicly available on registry
September 27, 2016
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFebruary 21, 2020
February 1, 2020
2.3 years
September 24, 2016
February 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (4)
68Ga-NODAGA-ZIGF-1R:4：40：IGF-1R+++
EXPERIMENTALPatients in this group had IGF-1R overexpression tumors and did not receive any treatment before this study.
68Ga-NODAGA-ZIGF-1R:4：40：IGF-1R++
EXPERIMENTALPatients in this group had IGF-1R moderate expression tumors and did not receive any treatment before this study.
68Ga-NODAGA-ZIGF-1R:4：40：IGF-1R+
EXPERIMENTALPatients in this group had IGF-1R low expression tumors and did not receive any treatment before this study.
68Ga-NODAGA-ZIGF-1R:4：40：healthy volunteers
EXPERIMENTALPatients in this group who are healthy volunteer.
Interventions
No Intervention
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Could not get pathological and gene detection results
- Pregnancy
- do not want to write informed consent。
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, 150028, China
Study Officials
- STUDY CHAIR
Baozhong Shen
The Fourth Hospital of Harbin Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief
Study Record Dates
First Submitted
September 24, 2016
First Posted
September 27, 2016
Study Start
September 1, 2018
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
February 21, 2020
Record last verified: 2020-02