NCT02441972

Brief Summary

The purpose of this study is to determine whether 18F-Al labeled RGD is safety and effective for cancer diagnosis and therapy response.

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
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_1

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

January 1, 2012

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 10, 2017

Status Verified

December 1, 2016

Enrollment Period

8.9 years

First QC Date

April 21, 2015

Last Update Submit

March 9, 2017

Conditions

TumorsCarcinoma, BronchogenicBreast CarcinomaCancer of Head and NeckLymphoma, MalignantSoft Tissue Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Safety data included vital signs (blood pressure, respiratory rate, heart rate, and body temperature) (composite)

    Safety data were collected before and after injection of 18F-Al-NOTA-PRGD2. physical examination; ECG; laboratory parameters (blood routine, liver function and kidney function) and adverse events.

    1 day

Secondary Outcomes (2)

  • radioactive distribution of normal organ, standard uptake value of tumor

    60 minutes

  • Diagnostic performance analysis to assess "sensitivity,specificity,accuracy,etc"

    1 day-1 year

Study Arms (1)

18F-Al-NOTA-PRGD2 PET/CT

EXPERIMENTAL

Imaging with 18F-Al-NOTA-PRGD2 PET/CT.

Drug: 18F-Al-NOTA-PRGD2 PET/CT

Interventions

18F-Al-NOTA-PRGD2 PET/CTDRUG

18F-Al-NOTA-PRGD2(PET imaging agent) given by vein before PET scans.Perform PET/CT for each enrolled volunteer or patient at 60-90min.

Also known as: 18F-Alfatide II PET/CT
18F-Al-NOTA-PRGD2 PET/CT

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteers or patients with age more than 18 yeas;
  • The patients have been diagnosed with cancer or suspected with cancer;
  • It must fulfill the ethical requirements and subjects have signed an informed consent.

You may not qualify if:

  • Pregnancy or nursing mothers;
  • Having drugs or alcohol dependence;
  • Hypersensitive to the active or inactive ingredients of the study drug;
  • Having attended other drug clinical trials within three months;
  • Cardiac functional insufficiency;
  • Hepatic and renal function insufficiency;
  • Hypertensive patients with serious complications;
  • Endangering the safety of life.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuxi No. 4 People's Hospital

Wuxi, Jiangsu, 214000, China

RECRUITING

Related Publications (3)

  • Beer AJ, Haubner R, Sarbia M, Goebel M, Luderschmidt S, Grosu AL, Schnell O, Niemeyer M, Kessler H, Wester HJ, Weber WA, Schwaiger M. Positron emission tomography using [18F]Galacto-RGD identifies the level of integrin alpha(v)beta3 expression in man. Clin Cancer Res. 2006 Jul 1;12(13):3942-9. doi: 10.1158/1078-0432.CCR-06-0266.

    PMID: 16818691RESULT

  • Beer AJ, Lorenzen S, Metz S, Herrmann K, Watzlowik P, Wester HJ, Peschel C, Lordick F, Schwaiger M. Comparison of integrin alphaVbeta3 expression and glucose metabolism in primary and metastatic lesions in cancer patients: a PET study using 18F-galacto-RGD and 18F-FDG. J Nucl Med. 2008 Jan;49(1):22-9. doi: 10.2967/jnumed.107.045864. Epub 2007 Dec 12.

    PMID: 18077538RESULT

  • Wang L, Zhu X, Xue Y, Huang Z, Zou W, Zhang Z, Yu M, Pan D, Wang K. Ultrasensitive detection of uveal melanoma using [18F]AlF-NOTA-PRGD2 PET imaging. EJNMMI Res. 2024 Jul 5;14(1):62. doi: 10.1186/s13550-024-01123-4.

    PMID: 38967722DERIVED

MeSH Terms

Conditions

NeoplasmsCarcinoma, BronchogenicBreast NeoplasmsHead and Neck NeoplasmsLymphomaSoft Tissue Neoplasms

Condition Hierarchy (Ancestors)

Bronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Weixing Wan, Professor

    Wuxi No. 4 People's Hospital

    STUDY CHAIR

Central Study Contacts

Chunjing Yu, Dr.

CONTACT

86-15312238622ycj_wxd1978@163.com

Study Design

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

Study Record Dates

First Submitted

April 21, 2015

First Posted

May 12, 2015

Study Start

January 1, 2012

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 10, 2017

Record last verified: 2016-12

Locations

CN(1)