NCT01737112

Brief Summary

This is an open-label SPECT/CT (single photon emission computed tomography / computed tomography) study to investigate the safety and diagnostic performance of 99mTc-3PRGD2 in evaluation of lung 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 lung 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

43
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 P75+ for early_phase_1 lung-cancer

Timeline
Completed

Started Feb 2011

Longer than P75 for early_phase_1 lung-cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

6.8 years

First QC Date

November 27, 2012

Last Update Submit

April 5, 2017

Conditions

Lung Cancer

Keywords

Lung Cancerintegrin αvβ3 receptor99mTc-3PRGD2SPECT/CTefficacy and safety

Outcome Measures

Primary Outcomes (1)

  • Visual and semiquantitative assessment of lesions and biodistribution

    Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician. The semiquantitative analysis will be performed by the same person for all the cases, and the tumor to background ratios(T/B) will be measured.

    One year

Secondary Outcomes (1)

  • Adverse events collection

    One year

Study Arms (1)

99mTc-3PRGD2 SPECT/CT scanning

EXPERIMENTAL

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

Drug: 99mTc-3PRGD2

Interventions

99mTc-3PRGD2DRUG

For patients in suspicion of lung 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
99mTc-3PRGD2 SPECT/CT scanning

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 18F-FDG PET/CT 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, Peking Union Medical College Hopital, Chinese Academy of Medical Science

Beijing, 100730, China

RECRUITING

Related Publications (1)

  • Miao W, Zheng S, Dai H, Wang F, Jin X, Zhu Z, Jia B. Comparison of 99mTc-3PRGD2 integrin receptor imaging with 99mTc-MDP bone scan in diagnosis of bone metastasis in patients with lung cancer: a multicenter study. PLoS One. 2014 Oct 22;9(10):e111221. doi: 10.1371/journal.pone.0111221. eCollection 2014.

    PMID: 25338281DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Fang Li, MD

    Department of Nuclear Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Science

    STUDY CHAIR

Central Study Contacts

Fang Li, MD

CONTACT

86-10-69155502lifang@pumch.cn

Zhaohui Zhu, MD

CONTACT

86-10-69154196zhu_zhaohui@yahoo.cn

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2012

First Posted

November 29, 2012

Study Start

February 1, 2011

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 7, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)