NCT01527058

Brief Summary

This is an open-label dynamic whole-body PET/CT (positron emission tomography/computed tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of 68Ga-BNOTA-PRGD2 in healthy volunteers and lung cancer patients. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 ( ≤ 40 µg BNOTA-PRGD2) will be intravenously injected into healthy volunteers and lung cancer patients. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine aminotransferase, albumin, and creatinine, and any adverse events will be collected from the volunteers. Adverse events will also be observed in 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 Dec 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

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2012

Completed
5.8 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

November 1, 2014

Enrollment Period

6 years

First QC Date

January 30, 2012

Last Update Submit

April 5, 2017

Conditions

Lung Cancer

Keywords

lung cancerintegrin receptor68Ga-BNOTA-PRGD2PET/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 standardized uptake values (SUVs) of tumor and organs will be measured.

    One year

Secondary Outcomes (10)

  • Blood pressure

    One year

  • Pulse

    One year

  • Respiration frequency

    One year

  • Temperature

    One year

  • Routine blood test

    One year

  • +5 more secondary outcomes

Study Arms (1)

68Ga-BNOTA-PRGD2 PET/CT scanning

EXPERIMENTAL

Determine if 68Ga-BNOTA-PRGD2 PET/CT is safe and effective method for imaging of lung cancer

Drug: 68Ga-BNOTA-PRGD2

Interventions

68Ga-BNOTA-PRGD2DRUG

Cancer patients, single intravenous bolus injection of nearly 111 MBq 68Ga-NOTA-PRGD2 on day one of the treatment period, dynamic whole-body PET/CT for determination of effective dose, kinetics of 68Ga-BNOTA-PRGD2 in blood, organs, and tumors Healthy volunteers, single intravenous bolus injection of nearly 111 MBq 68Ga-BNOTA-PRGD2 on day one of the treatment period, dynamic whole-body PET/CT for determination of effective dose, kinetics of 68Ga-BNOTA-PRGD2 in blood and organs

Also known as: 68Ga-p-SCN-Bn-NOTA-PEG3-RGD2
68Ga-BNOTA-PRGD2 PET/CT scanning

Eligibility Criteria

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

You may qualify if:

  • Healthy volunteers:
  • Males and females, ≥30 and ≤ 70 years old
  • Cancer patients:
  • Males and females, ≥30 years old
  • 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
  • Renal function: serum creatinine \>3.0 mg/dL (270 μM/L)
  • Liver function: any hepatic enzyme level more than 5 times upper limit of normal.
  • Known severe allergy or hypersensitivity to IV radiographic contrast.
  • Patients not able to enter the bore of the PET/CT scanner.
  • 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

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

68gallium-BNOTA-PRGD2

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

86-10-65295502lifang@pumch.cn

Zhaohui Zhu, MD, PhD

CONTACT

86-10-13611093752zzh_1969@yahoo.com.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

January 30, 2012

First Posted

February 6, 2012

Study Start

December 1, 2011

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 7, 2017

Record last verified: 2014-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)