Brief Summary

The investigators developed \[68Ga\]-labelling Anti-EGFR Affibody Molecule as a targeted molecular imaging agent for noninvasive and repeatable detecting EGFR-ECD expression status.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

100

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

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

2 years study duration

Study Start

First participant enrolled

September 1, 2016

Completed

23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2016

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed

4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed

1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed

Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

1 month

First QC Date

September 24, 2016

Last Update Submit

September 24, 2016

Conditions

Molecular Imaging

Outcome Measures

Primary Outcomes (1)

tumor SUVmax value of 68Ga-NODAGA-ZEGFR:1907 PET/CT Imaging
To quantify the accumulation, a volume of interest using a 3-D sphere, was placed over the primary lung tumor, lymph nodes and distant metastases avoiding necrosis, blood vessels and normal lung tissue 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.
at time of imaging

Study Arms (6)

68Ga-ZEGFR: EGFR++

EXPERIMENTAL

Patients in this group had EGFR-activating mutant and EGFR high expression tumors and did not receive any treatment before this study.