NCT02744729

Brief Summary

This is an open-label single photon emission computed tomography / computed tomography (SPECT/CT) study to investigate the safety and diagnostic performance of 99mTc-HYNIC-3PEG4-E\[c(RGDfK)2) (99mTc-3PRGD2) in esophagus cancer patients. A single dose of nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the patients in suspicion of esophagus cancer. Visual and semiquantitative method will be used to assess the whole-body planar and thoracic SPECT/CT images. Any adverse events will be collected from the patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2020

Enrollment Period

1.3 years

First QC Date

March 8, 2016

Last Update Submit

July 30, 2020

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (2)

  • Visual Assessment of Esophagus Lesions in 99mTc-3PRGD2 SPECT/CT Scan

    Visual analysis will be performed by 3 experienced nuclear medicine physicians to observe the the uptake of 99mTc-3PRGD2 on esophagus lesions. The visual analysis interpreter's degree of suspicion for an abnormality was recorded with use of a 3-point with the following categories: score 1, no abnormal increased uptake; score 2, mildly increased uptake; score 3, definite focal increased uptake. The lesion was considered positive as malignancy if the lesion scored as 2 or higher.

    one year

  • Semiquantitative Assessment of Esophagus Lesions in 99mTc-3PRGD2 SPECT/CT Scan

    The semiquantitative analysis of the standardized uptake values (SUV) of 99mTc-3PRGD2 SPECT/CT was performed on esophagus lesion

    one year

Secondary Outcomes (4)

  • 18F-FDG PET/CT Scan

    one year

  • Laboratory Values

    one year

  • Adverse events collection

    5 days

  • Contrast-enhanced CT

    one year

Study Arms (1)

Esophagus Cancer, 99mTc-3PRGD2, SPECT/CT

EXPERIMENTAL

Determine if 99mTc-3PRGD2 SPECT/CT is safe and effective in diagnosis of Esophagus cancer patients.

Drug: 99mTc-3PRGD2

Interventions

99mTc-3PRGD2DRUG

For patients in suspicion of esophagus cancer, single intravenous bolus injection of nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 on day one of the treatment period, whole-body planar and thoracic SPECT/CT to determine the accumulation of 99mTc-3PRGD2 in the tumors and the other parts of the body.

Also known as: 99mTc-HYNIC-3PRGD2
Esophagus Cancer, 99mTc-3PRGD2, SPECT/CT

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females, ≥30 years old
  • Thoracic CT and/or gastroscopy diagnosis in suspicion of primary or recurrent lung cancer.
  • The lung cancer will be histologically confirmed or results of histology will be available.

You may not qualify if:

  • Females planning to bear a child recently or with childbearing potential
  • Known severe allergy or hypersensitivity to IV radiographic contrast.
  • Inability to lie still for the entire imaging time because of cough, pain, etc.
  • Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
  • Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Weibing Miao, MD

    First Affiliated Hospital of Fujian Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 8, 2016

First Posted

April 20, 2016

Study Start

October 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

August 3, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Locations

CN(1)