NCT02965001

Brief Summary

Head and neck cancer (HNC) is the 6th most common cancer worldwide. In the last decade, there has been made substantial improvements in diagnosis, staging and treatment of HNC. The overall survival has improved, but for some subgroups it is unchanged and therefore new prognostic and surveillance methods are warranted. One of the hallmarks in cancer is the ability to invade the surrounding tissue and metastasize. Studies have shown that the urokinase proteolytic plasminogen activator (uPA) and its receptor (uPAR) are present at the very front of the invasive tumor and they are considered essential in cancer invasion and metastasis. Consequently, an uPAR-targeted tracer offers a very promising target for functional PET imaging and may be a stronger prognostic marker compared to routine FDG-PET/CT. We wish to clarify how uPAR-PET/CT correlate to patient outcome compared to routine FDG-PET/CT in patients with HNC in the pharynx, larynx and oral cavity, who are referred to curative intended radiotherapy. In this project all participants have an uPAR-PET/CT scan performed before initiation of the routine radiotherapy and the prognostic efficacy is determined by assessment of the recurrence rate and mortality at routine clinical follow-up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Nov 2016

Typical duration for phase_2 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

5.1 years

First QC Date

November 14, 2016

Last Update Submit

November 1, 2022

Conditions

Head and Neck Cancer

Keywords

Molecular ImaginguPAR-PET/CTHead and neck cancercurative intended radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Freedom from any failure

    1-3 years

Secondary Outcomes (4)

  • Overall Survival

    1-3 years

  • Disease free survival

    1-3 years

  • Distant metastasis free survival

    1-3 years

  • Loco-regional control

    1-3 years

Study Arms (1)

68Ga-NOTA-AE105

EXPERIMENTAL

All participants have an uPAR-PET/CT scan performed before initiation of the routine radiotherapy

Drug: 68Ga-NOTA-AE105

Interventions

68Ga-NOTA-AE105DRUG

The patients are refered to an uPAR-PET/CT scan before initiation of the routine radiotherapy and the prognostic efficacy is assessed by registration of recurrence rate and death at routine clinical follow-up.

Also known as: uPAR
68Ga-NOTA-AE105

Eligibility Criteria

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

You may qualify if:

  • has a diagnosis of biopsy-verified cancer of the pharynx, larynx or oral cavity
  • is referred to curative intended radiotherapy
  • understands the given information and has given informed consent and
  • age above 18 years.

You may not qualify if:

  • Pregnancy, lactation/breast feeding, age above 85 years, obesity (bodyweight above 140 kg), small cancers of the larynx (1A,1B), allergy to 68Ga-NOTA-AE105, metastasis on FDG-PET/CT, other previously known cancers, claustrophobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departmen of Physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • Risor LM, Clausen MM, Ujmajuridze Z, Farhadi M, Andersen KF, Loft A, Friborg J, Kjaer A. Prognostic Value of Urokinase-Type Plasminogen Activator Receptor PET/CT in Head and Neck Squamous Cell Carcinomas and Comparison with 18F-FDG PET/CT: A Single-Center Prospective Study. J Nucl Med. 2022 Aug;63(8):1169-1176. doi: 10.2967/jnumed.121.262866. Epub 2021 Dec 2.

    PMID: 34857658DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Andreas Kjær, Professor

    Rigshospitalet, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, medical doctor, Ph.D student

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 16, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

November 3, 2022

Record last verified: 2022-11

Locations

DK(1)