NCT02960724

Brief Summary

uPAR PET/CT for Staging Advanced and Localised oral and oropharyngeal cancer

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
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2016

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

First Submitted

Initial submission to the registry

October 11, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 10, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

November 10, 2016

Status Verified

November 1, 2016

Enrollment Period

1.7 years

First QC Date

October 11, 2016

Last Update Submit

November 7, 2016

Conditions

Oral CancerOropharyngeal CancerNeoplasmsHead and Neck NeoplasmsCancer of MouthNeoplasms by Site

Keywords

Uroplasminogen Plasminogen Activator ReceptorOropharyngeal canceroral cancerPositron Emission Tomography

Outcome Measures

Primary Outcomes (1)

  • The number of lymph node metastases that can be identified by means of uPAR PET / CT compared with the histological findings.

    Through study completion, an average of 1.5 year

Secondary Outcomes (3)

  • Evaluation of the correlation between uPAR PET signal (quantified as SUVmax) and the immunohistochemical expression of uPAR evaluated by an H-score (intensity x the percentage of stained tumor tissues throughout the tumor margin).

    Through study completion, an average of 1.5 year

  • Evaluation of the correlation between tumor burden (assessed v.h.a. TNM staging) uPAR-PET signal (assessed as SUVmax) and the amount of uPAR metabolites in plasma.

    Through study completion, an average of 1.5 year

  • Determination of the lower detection limit of the amount of tumor tissue for uPAR-PET correlated with the histological H-score x tumor size (where tumor size is evaluated on the pathological preparation of pathologist)

    Through study completion, an average of 1.5 year

Study Arms (1)

68Ga-NOTA-AE105 PET/CT

EXPERIMENTAL

One injection of 68Ga-NOTA-AE105 followed by positron emission tomography/computed tomography (PET/CT scan) will be performed before surgery and compared with the histological findings to evaluate uPAR PET/CT in staging of oral cancer and oropharyngeal cancer.

Other: 68Ga-NOTA-AE105 PET/CT

Interventions

68Ga-NOTA-AE105 PET/CTOTHER

One injection of 68Ga-NOTA-AE105 (app. 200 Mbq) followed by Positron Emission Tomography Scan.

68Ga-NOTA-AE105 PET/CT

Eligibility Criteria

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

You may qualify if:

  • Able to understand patient information and to give informed consent
  • Not previously irradiated or operated on neck
  • Operable disease
  • Study I OSCC cN0 verified histologically by pathologic examination of biopsy
  • Study II OSCC or OPSCC N + verified histologically by pathologic examination of biopsy

You may not qualify if:

  • Pregnancy
  • Patients who are candidates for curative intentional radiation
  • Patients who have had surgery or radiation therapy to the neck as this may alter the lymph drainage.
  • Age under 18 or over 85 years
  • Obesity\> 140 kg
  • Allergy to 68Ga-NOTA-AE105

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (3)

  • Skovgaard D, Persson M, Brandt-Larsen M, Christensen C, Madsen J, Klausen TL, Holm S, Andersen FL, Loft A, Berthelsen AK, Pappot H, Brasso K, Kroman N, Hojgaard L, Kjaer A. Safety, Dosimetry, and Tumor Detection Ability of 68Ga-NOTA-AE105: First-in-Human Study of a Novel Radioligand for uPAR PET Imaging. J Nucl Med. 2017 Mar;58(3):379-386. doi: 10.2967/jnumed.116.178970. Epub 2016 Sep 8.

    PMID: 27609788RESULT

  • Persson M, Skovgaard D, Brandt-Larsen M, Christensen C, Madsen J, Nielsen CH, Thurison T, Klausen TL, Holm S, Loft A, Berthelsen AK, Ploug M, Pappot H, Brasso K, Kroman N, Hojgaard L, Kjaer A. First-in-human uPAR PET: Imaging of Cancer Aggressiveness. Theranostics. 2015 Sep 13;5(12):1303-16. doi: 10.7150/thno.12956. eCollection 2015.

    PMID: 26516369RESULT

  • Persson M, Nedergaard MK, Brandt-Larsen M, Skovgaard D, Jorgensen JT, Michaelsen SR, Madsen J, Lassen U, Poulsen HS, Kjaer A. Urokinase-Type Plasminogen Activator Receptor as a Potential PET Biomarker in Glioblastoma. J Nucl Med. 2016 Feb;57(2):272-8. doi: 10.2967/jnumed.115.161703. Epub 2015 Oct 1.

    PMID: 26429955RESULT

MeSH Terms

Conditions

Mouth NeoplasmsOropharyngeal NeoplasmsNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Andreas Kjær, MD,DMSc,PhD

    Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD-student

Study Record Dates

First Submitted

October 11, 2016

First Posted

November 10, 2016

Study Start

November 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

November 10, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)