Who is sponsoring NCT00520546?

NCT00520546 is sponsored by Dr. Markus Hartenbach.

What drugs are being tested in NCT00520546?

Interventions in NCT00520546: 18F-Ethylcholine Positron Emission Tomography (FEC-PET), Endorectal Magnetic Resonance Imaging (1.5Tesla) (eMRI).

What condition does NCT00520546 study?

NCT00520546 studies Prostate Cancer.

Is NCT00520546 still recruiting?

NCT00520546 is currently completed. Last updated 3 June 2012.

Are results published for NCT00520546?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2012-06-03 · How we verify

NCT00520546: FEC-PET/MRI

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Value of [18]Fluoroethylcholine Positron-Emission-Tomography Combined With Endorectal Magnetic Resonance Imaging by Software Fusion for Pre-therapeutic Staging of Prostate Cancer

Completed Phase 3 Results posted Last updated 3 June 2012

What this trial tests

Phase 3 trial testing 18F-Ethylcholine Positron Emission Tomography (FEC-PET) in Prostate Cancer in 44 participants. Completed in 1 June 2011.

Timeline

1 December 2007

Primary endpoint
1 February 2011

1 June 2011

Quick facts

Lead sponsor	Dr. Markus Hartenbach
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	44
Start date	1 December 2007
Primary completion	1 February 2011
Estimated completion	1 June 2011
Sites	1 location across Germany

Drugs / interventions tested

18F-Ethylcholine Positron Emission Tomography (FEC-PET)
Endorectal Magnetic Resonance Imaging (1.5Tesla) (eMRI)

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Dr. Markus Hartenbach

Who can join

50 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of Participants With Positive or Negative Results in PET, MRI or PET/MRI for Prostate Cancer Compared to Histological Findings
Time frame: within < 2 weeks after PET/MRI
PET positive lesions were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone

Sponsor's own description

To investigate the sensitivity of the \[18F\]fluoroethylcholine (FEC) Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) method in tumour detection and location (side assignment, encapsulation, invasion of the seminal vesicle) and detection of affected lymph nodes, and to compare these with presently used detection procedures (needle biopsy, digital rectal examination, transrectal ultrasound, and pre-therapeutic assessment), with a view to finding out whether the \[18F\]fluoroethylcholine PET/MRI method is comparable to, or superior to, the established method. Postoperative histology served as the standard of reference.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00520546 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dr. Markus Hartenbach
Last refreshed: 3 June 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00520546.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing