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99mTc-3PRGD2 SPECT/CT for Integrin Imaging of Lung Cancer

NCT04233476 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 409

Last updated 2024-07-01

No results posted yet for this study

Summary

This is a prospective, multicenter, self-controlled phase 3 clinical trial designed to evaluate the safety and efficacy of an integrin αVβ3-targeted imaging, 99mTc-3PRGD2 SPECT/CT, for diagnosis of lung cancer and mapping the lymph node metastases. The pathological results will be considered as the gold standard and the conventional metabolic imaging by 18F-FDG PET/CT will be used for a head-to-head comparison. The primary objective of this study is to evaluate the efficacy of 99mTc-3PRGD2 SPECT/CT in mapping of lymph node metastasis according to the nodal mapping system released by the International Association for the Study of Lung Cancer in 2009 (IASLC-2009). The secondary objectives include evaluation of 99mTc-3PRGD2 SPECT/CT in detection of lung cancer and the safety of 99mTc-3PRGD2 injection in human beings.

Conditions

Interventions

DRUG

99mTc-3PRGD2 injection

A diagnostic drug targeting integrin αvβ3, technetium-99m \[99mTc\] labeled hydrazinonicotinamide-PEG4-E\[PEG4-c(RGDfk)\]2 (99mTc-3PRGD2), will be intravenously injected to the participants for imaging of lung cancer and mapping lymph node metastasis via single photon emission computed tomography/ X-ray computed tomography (SPECT/CT) .

Sponsors & Collaborators

  • Beijing Pharbers Genesis Pharmaceutical Technology Co., Ltd.

    collaborator INDUSTRY

  • RDO Pharm.

    lead INDUSTRY

Principal Investigators

  • Zhaohui Zhu, MD, PhD · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-12
Primary Completion
2021-05-08
Completion
2021-05-08

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04233476 on ClinicalTrials.gov