NCT02327442

Brief Summary

The purpose of this study is to assess the safety, biodistribution, dosimetric properties of the positron emission tomography (PET) radiopharmaceutical agent 68Ga-NOTA-NFB. To preliminarily evaluate its application in glioma diagnosis. To assess the application of 68Ga-NOTA-NFB PET/CT in the evaluation of the neoadjuvant chemotherapy in patients with breast cancer before and after the therapy.

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
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2014

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

June 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 30, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

1.5 years

First QC Date

December 23, 2014

Last Update Submit

December 29, 2014

Conditions

GliomaBreast Cancer

Keywords

chemokine receptorgaliumdosimetryglioma

Outcome Measures

Primary Outcomes (4)

  • SUV of organs

    The standardized uptake values (SUV) in deferent organs are calculated.

    0, 0.5, 1.0, 2.0, and 3.0hours after injection

  • radioactivity of blood sample

    blood samples are obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, and 180 minutes after the injection, for time-radioactivity curve calculations.

    1, 3, 5, 10, 30,60, 90, 120, 150, and 180minutes

  • SUV of glioma

    The maximum standardized uptake values (SUVmax) and the maximum target to non-target ratios (T/NTmax) of 68Ga-NOTA-NFB and 18F-FDG in glioma tissues.

    1 hour after injection

  • SUV of Breast Cancer

    The maximum standardized uptake values (SUVmax) of 68Ga-NOTA-NFB and 18F-FDG in breast cancer before and after neoadjuvant chemotherapy.

    1 hour after injection

Study Arms (3)

Volunteers

Healthy Volunteers undergo whole-body 68Ga-NOTA-NFB PET/CT scans 0, 0.5, 1.0, 2.0, and 3.0 hours after tracer injection. During the imaging period, 1 mL blood samples are obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, and 180 minutes after the injection, for time-activity curve calculations.

Radiation: 68Ga-NOTA-NFB

Glioma Patients

Glioma Patients enrolled for the clinical study of diagnosing glioma are performed with both 68Ga-NOTA-NFB PET/CT and18F-FDG PET/CT scans before surgery.

Radiation: 68Ga-NOTA-NFB

Breast Cancer Patients

68Ga-NOTA-NFB PET/CT and 18F-FDG PET/CT scans will undergo in patients with breast cancer before and after neoadjuvant chemotherapy.

Radiation: 68Ga-NOTA-NFB

Interventions

68Ga-NOTA-NFBRADIATION

In this investigation, 68Ga-NOTA-NFB is employed to a preclinical trial, including radiation dosimetry study in healthy volunteers and the first application in glioma patients, to assess the safety, dosimetry property and evaluate the CXCR4 expression in glioma patients and breast cancer patients.

Breast Cancer PatientsGlioma PatientsVolunteers

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

6 healthy volunteers. 10 patients with glioma before surgery. 30 patients with breast cancer before and after neoadjuvant chemotherapy.

You may qualify if:

  • volunteers : healthy patients with glioma: diagnosed by MR and ready for surgery patients with breast: cancer appropritate of neoadjuvant chemotherapy.

You may not qualify if:

  • patients with glioma: refuse or cannot endure surgery. patients with breast: refuse neoadjuvant chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital Nuclear Medicine Department

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

GliomaBreast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jing Wang, Doctor

    Xijing Hospital

    STUDY DIRECTOR

Central Study Contacts

Jing Wang, Doctor

CONTACT

86-29-84775449wangjing@fmmu.edu.cn

Zhe Wang, Doctor

CONTACT

86-29-84771048dadaxueshan@163.com

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2014

First Posted

December 30, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations

CN(1)