Magnetometer guided sentinel lymphadenectomy after marking with superparamagnetic iron oxide nanoparticles versus extended lymphadenectomy in prostate cancer: rate of detection and sensitivity in comparison
Organizational Data
- DRKS-ID:
- DRKS00007671
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2015-01-09
- Last update in DRKS:
- 2023-10-04
- Registration type:
- Prospective
Acronym/abbreviation of the study
SentiMagPro II
URL of the study
No Entry
Brief summary in lay language
The aim of this study is to validate a new method for magnetic labeling and targeted removal of sentinel lymph nodes in prostate cancer. Prostate cancer spreads mainly via the lymphatic system. The reliable detection of lymph node metastases is of great importance . The surgical lymph node removal is currently the most reliable method for the detection of lymph node metastases in prostate cancer. The so-called sentinel lymph nodes are the first tumor draining lymph nodes. The sentinel technique was etablished in prostate cancer similar to other types of cancer (e.g. breast cancer and melanoma). So far, the sentinel lymph nodes were labeled with a radioactive material (technetium-99m nannokolloid) . Now is the opportunity to make the mark with a magnetic material , which has already been carried out successfully in breast cancer. The feasebility of this new magnetic aproach has also been shown in prostate cancer patients (SentiMagPro study, n=20, Winter et al. Ann Surg Oncol, 2014). In this study the detection rate and the sensitivity of magnetic marking and detection of sentinel lymph nodes is further investigated in a larger collective (n=50). For the magnetic labeling of the sentinel lymph nodes a magnetic tracer (Sienna +) is injected into the prostate one day before surgery. In the operation a magnometer guided sentinel lymphadenectomy and a conventional lymphadenectomy are performed. Participation is open to patients for whom a lymph node dissection is recommended as part of a radical prostatectomy according to the German guidelines (intermediate or high risk prostate cancer: PSA greater than 10 ng / mL and/or Gleason score greater than or equal to 7). Sienna+ is injected into the prostate one day before surgery. In the surgery all lymph nodes detected by the SentiMag probe are removed. In addition, a conventional lymphadenectomy is performed.
Brief summary in scientific language
The SentiMag / Sienna + system for marking and detection of sentinel lymph nodes has already been successfully established in breast cancer into clinical routine. The feasebility of this new magnetic approach has also been shown in prostate cancer patients (SentiMagPro study, n=20, Winter et al. Ann Surg Oncol, 2014). In this study the detection rate and the sensitivity of magnetic marking and detection of sentinel lymph nodes is further investigated in a larger collective (n=50). Sienna+ is injected transrectally into the prostate under ultrasound guidance one day before surgery. In the surgery all lymph nodes detected by the SentiMag probe are removed. In addition, a conventional extended lymphadenectomy is performed. Patients with an intermediate or high-risk prostate cancer (PSA greater than 10 ng / ml and / or Gleason score greater than or equal to 7) will be enrolled.
Health condition or problem studied
- ICD10:
- C61 - Malignant neoplasm of prostate
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- transrectally injection of superparamagnetic iron oxid nanoparticles (Sienna+, 2 ml) into the prostate using ultrasound guidence 1 day before surgery; magnetometer guided sentinel lymph node dissection and extended lymphadenectomy in combination with a radical retropubic prostatectomy
Endpoints
- Primary outcome:
- Intraoperative detection rate of sentinel lymph nodes: number of patients with at least one intraoperative sentinel lymph node detected by magnetometer (SentiMag) guidence / number of operated patients in total
- Secondary outcome:
- Sensitivity of the SentiMag method in detection of lymph node metastases: - based on patients: number of patients with positive sentinel lymph nodes / total number of patients with positive lymph nodes - based on lymph nodes: number of positive sentinel lymph nodes / total number of positive lymph nodes
Study Design
- Purpose:
- Diagnostic
- Allocation:
- N/A (single arm study)
- Control:
-
- Uncontrolled/single arm
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Single (group)
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Universitätsklinik für Urologie, Klinikum Oldenburg, Fakultät für Medizin und Gesundheitswissenschaften, Carl von Ossietzky Universität Oldenburg Oldenburg
Recruitment period and number of participants
- Planned study start date:
- 2015-02-02
- Actual study start date:
- 2015-02-24
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2015-09-01
- Target Sample Size:
- 50
- Final Sample Size:
- 50
Inclusion Criteria
- Sex:
- Male
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- intermediate or high risk Prostate cancer: PSA greater than 10 and/or Gleason score graeter or equal to 7
Exclusion Criteria
Intolerance / hypersensitivity to iron or dextran or Sienna +, patients with iron overload disease, cardiac pacemakers or other in the chest wall implanted devices, patients with hip prostheses or other metallic implants in the pelvic area, patients with previous surgery on the prostate (eg transurethral prostate resection, adenomectomy, laser enucleation); patient, who are not capable of giving consent
Addresses
Primary Sponsor
- Address:
- Universitätsklinik für Urologie, Klinikum Oldenburg, Fakultät für Medizin und Gesundheitswissenschaften, Carl von Ossietzky Universität OldenburgDr. med. Alexander WinterRahel-Straus-Str. 1026133 OldenburgGermany
- Telephone:
- 04414032302
- Fax:
- 04414032137
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinik für Urologie, Klinikum Oldenburg, Fakultät für Medizin und Gesundheitswissenschaften, Carl von Ossietzky Universität OldenburgDr. med. Alexander WinterRahel-Straus-Str. 1026133 OldenburgGermany
- Telephone:
- 04414032302
- Fax:
- 04414032137
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universitätsklinik für Urologie, Klinikum Oldenburg, Fakultät für Medizin und Gesundheitswissenschaften, Carl von Ossietzky Universität OldenburgDr. med. Alexander WinterRahel-Straus-Str. 1026133 OldenburgGermany
- Telephone:
- 04414032302
- Fax:
- 04414032137
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsklinik für Urologie, Klinikum Oldenburg, Fakultät für Medizin und Gesundheitswissenschaften, Carl von Ossietzky Universität OldenburgDr. med. Alexander WinterRahel-Straus-Str. 1026133 OldenburgGermany
- Telephone:
- 04414032302
- Fax:
- 04414032137
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Carl von Ossietzky Universität OldenburgAmmerländer Heerstr. 114-11826129 OldenburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission bei der Ärztekammer Niedersachsen, Unterkommission zur Beurteilung medizinischer Forschung am MenschenKarl-Wiechert-Allee 18-2230625 HannoverGermany
- Telephone:
- +49-511-3802208
- Fax:
- +49-511-3802119
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2014-07-29
- Ethics committee number:
- Bo/24/2014
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2014-09-08
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- Winter, A et al. (2016) Magnetometer guided sentinel lymphadenectomy after intraprostatic injection of super-paramagnetic iron oxide nanoparticles in intermediare and high risk prostate cancer patients. J Urol 2016; 195 (4, Suppl), e987
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Winter A, Engels S, Goos P, Süykers M-C, Gudenkauf S, Henke R-P, Wawroschek F. Accuracy of Magnetometer-Guided Sentinel Lymphadenectomy after Intraprostatic Injection of Superparamagnetic Iron Oxide Nanoparticles in Prostate Cancer: The SentiMag Pro II Study. Cancers. 2020; 12(1):32. https://doi.org/10.3390/cancers12010032
- Date of first publication of study results:
- 2019-12-20
- DRKS entry published for the first time with results:
- 2021-07-05
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry