NCT03307460

UnknownPhase 2

uPAR-PET/MRI in Patients With Prostate Cancer for Evaluation...

Copenhagen University Hospital, Rigshospitalet Source

Copenhagen University Hospital, Rigshospitalet

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

AK-2017-PC-1

Secondary identifiers

2017-002276-37

EUDRACT_NUMBER

2017

NIH

Study Type

interventional

Actual enrollment (reported)

52

Locations

1 country

Sites

1

Timeline

Study Start

November 21, 2017

Actual (reported)

Primary Completion

October 11, 2019

Actual (reported)

Study Completion

April 1, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

Prospective study to evaluate the value of uPAR-targeted PET/MR scan using the tracer 68Ga-NOTA-AE105 in patients with newly diagnosed prostate cancer

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Actual enrollment (reported): 52 participants
Study completion date: April 1, 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
October 6, 2017
Actual (reported)
First Posted
October 11, 2017
Actual (reported)
Study Start
November 21, 2017
Actual (reported)
Primary Completion
October 11, 2019
Actual (reported)
Study Completion
April 1, 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: November 23, 2020
Status Verified: November 2020
Last Update Submitted: November 20, 2020

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

Correlation with Gleason Score
Correlate the uptake of 68Ga-NOTA-AE105 with Gleason Score obtained from biopsy material.
3 months after PET/MRI

Secondary Outcomes (2)

Prognostic value
3 years from PET/MRI
Diagnostic accuracy in staging lymph nodes
3 months from PET/MRI

Study Arms (1)

uPAR PET/MRI

EXPERIMENTAL

68Ga-NOTA-AE105 is injected once for performing a PET/MRI scan

Drug: 68Ga-NOTA-AE105

Interventions

68Ga-NOTA-AE105Drug

PET/MRI scan

Also known as: PET/MRI

uPAR PET/MRI

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically verified prostate cancer
Capable of understanding written information and giving informed consent

Sponsors & Collaborators

Copenhagen University Hospital, Rigshospitalet
Otherlead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

Marie Ø Fosboel, MD
Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET
PRINCIPAL INVESTIGATOR

Enrollment

52 participants (actual enrollment reported by the registry).

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: Medical doctor

Study Record Dates

First Submitted

October 6, 2017

First Posted

October 11, 2017

Study Start

November 21, 2017

Actual (reported)

NCT03001895

Correlation Between SUV on 18F-DCFPyL PET/CT and Gleason Score in Prostate Cancer

Phase 2Completed

NCT03062254

Metabolic Change in Prostate Cancer Bone Metastases on 68Ga-HBED-CC-PSMA PET/CT Following Radium-223 Therapy

Phase 2Completed

NCT03689582

Radiolabeled Gallium-68 (68Ga-PSMA) for PET/CT Imaging to Detect Prostate Cancer

Phase 2Terminated

NCT03604757

68Ga-RM2 Compared to 68Ga-PSMA-617 PET/CT for Prostate Cancer Imaging According to Various Metastatic Risks

Phase 2Completed

NCT02810886

Prospective Evaluation of 68Ga-PSMA PET-CT for Recurrence Detection of Prostate Cancer and Its Impact on Patient Management

Phase 2Withdrawn

NCT02796807

Correlation Between SUV on 68Ga-HBED-CC-PSMA and Gleason Score in Prostate Cancer

Phase 2Completed

Planned to enter active surveillance strategy or undergo therapy with curative intent (surgery or radiotherapy)

You may not qualify if:

Obesity (Body weight over 140 kg)
Known allergy to 68-Ga-NOTA-AE105
Metallic components in the body that contradicts MRI scan
Severe claustrophobia making the person unable to complete an MRI scan

Contact the study team to confirm eligibility.

Primary Completion

October 11, 2019

Actual (reported)

Study Completion

April 1, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

November 23, 2020

Record last verified: 2020-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03307460
Data provider: ClinicalTrials.gov
Source updated: 2020-11-23
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:45 UTC

Locations

DK(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

uPAR PET/MRI

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations