SPECT-CT Guided Lymphatic Mapping and Sentinel Lymphadenectomy (LM/SL) in Prostate Cancer
NCT ID: NCT00773318
Last Updated: 2012-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
30 participants
INTERVENTIONAL
2008-04-30
2012-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In prostate cancer, growing data indicate the potential utility of LM/SL, particularly in patients with a low pre-test probability of nodal disease. However, very few data have been reported on the feasibility and the utility of SPECT/CT following LM/SL. In a pilot study including 11 patients with prostate cancer, Kizu and colleagues used a software image fusion from separate SPECT and CT studies. These authors concluded to the utility of image fusion to localize anatomically the SLNs. They also suggested the use of hardware fusion from a single gantry SPECT/CT device for accurate detection of SLNs. Accordingly, Corvin and colleagues recently reported the suitability of sentinel node detection in a series of 28 patients with prostate cancer; in this study, an integrated single slice SPECT/CT device was used to localize the SLNs.
In the light of the encouraging data from literature and our own preliminary clinical experience, we hypothesized that the use of integrated SPECT/low-dose multislice CT guided LM/SL may be of clinical interest in patients with prostate cancer.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Single Photon Emission Computed Tomography (SPECT) Lymph Node Mapping
NCT00608920
Imaging for Significant Prostate Cancer Risk Evaluation
NCT01492270
Multispectral Fluorescence as a Tool to Separate Healthy and Disease Related Lymphatic Anatomies in Prostate Cancer.
NCT05120973
Multi-modality Prostate Cancer Image Guided Interventions
NCT04009174
A Pilot Study of 123I-MIP-1072 SPECT/CT Imaging With Optional Compact Gamma Camera Probe Imaging in Men With Prostate Cancer Undergoing Prostatectomy
NCT01279785
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is a 2-day protocol with a single isotopic tracer (Tc99m-cysteine rhenium colloids, 10-15 nm). The tracer injections will be performed under trans-rectal ultra-sound guidance (1 inj/lobe, 74MBq, 0.2 cc).
The first day or injection day (D0), an early imaging session with planar acquisitions (anterior and posterior views) will be performed within 30 min post-tracer injection. A delayed imaging session with planar and SPECT/CT acquisitions will be also performed 1 to 3 hours after tracer injection. The SPECT/CT device to be used in this research protocol is the Infinia Hawkeye 4-slice from GE Healthcare. This hybrid camera incorporates a low-dose CT with a 2.5 mA current (eff.dose \< 2mSv) on a dual-head gamma camera. SPECT/CT data will be analysed on the Xeleris 2.05v (Volumetrix for Hawkeye Oncology).
The second day (D+1 post-tracer injection), all prostate cancer patients will undergo a radical prostatectomy with complete pelvic lymph node dissection (CLND). Sentinel lymph nodes (SLNs) will be detected intra-operatively by using a gamma probe (Navigator, Tyco Healthcare). In this single tracer study, SLNs are defined as hot nodes only including the hottest node and any hot node ≥ 10% of the hottest node. In this SPECT/CT protocol, additional non-radioactive nodes eventually detected on the CT component and suspicious of tumor involvement (lymphadenopathies \> 1cm) will be also removed, especially lymph nodes located in unpredictable lymphatic basins. Surgery will be performed by the same surgeons.
SLNs and non-SLNs will be analyzed by the same pathologist. For SLNs, a Hematoxylin \& Eosin staining (H-E) will be firstly performed. If negative, 3 more H-E stains levels will be performed and immuno-peroxidase stains for Cytokeratins AE1/AE3, PSA, and PAP. Non-SLNs will be analyzed according to the routine protocol with 3 H-E stained levels only. The SLN features will be noted: number, anatomical localization in vivo, counting rates ex vivo. The pathological characteristics of metastatic SLNs and non-SLNs will be precisely recorded: size, involvement (micro-metastases ≤ 2mm; macro-metastases; isolated tumor cells), % of nodes involved (small \< 25%; moderate = 25-75%; massive \> 75%).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
Patients with histologically proven AJCC stages I - II - III prostate cancer including men with clinical T3N0M0 disease, men with PSA \> 10 mg/ml, and men with Gleason score of 8-10. Prostate cancer patients scheduled for prostatectomy and pelvic lymph node dissection (CLND).
Arm A = SPECT/CT guided LM/SL versus CLND
SPECT/CT guided LM/SL
Detection, localization, and removal of sentinel lymph node (s) from prostate cancer guided by an integrated SPECT/low-dose multislice CT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SPECT/CT guided LM/SL
Detection, localization, and removal of sentinel lymph node (s) from prostate cancer guided by an integrated SPECT/low-dose multislice CT
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Initial staging (Bone scan, CT, or MRI) according to the NCCN guidelines
* Patients with AJCC stages I - II - III prostate cancer including men with clinical T3N0M0 disease, men with PSA \> 10 mg/ml, and men with Gleason score of 8-10 (high grade disease)
* Prostate cancer patients will be scheduled for prostatectomy and pelvic lymph node dissection
* Informed consent signed by the patient
Exclusion Criteria
* Patient with regionally advanced disease or metastatic disease (T4, and/or N1, and/or M1)
* Patients with clinically and/or radiologically evident regional lymph node metastases
* Patients who are not scheduled for radical prostatectomy and pelvic lymph node dissection
* Patients with physical and/or psychological contraindications
* Recent studies in Nuclear Medicine with long half-time isotopes (i.e. T ½ \> 48h; 111In, 67Ga, 201Tl, 131I) performed within 1 week preceding the LM/SL
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
London Regional Cancer Program, Canada
OTHER
University of Western Ontario, Canada
OTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Irina Rachinsky
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Irina Rachinsky, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
The University of Western Ontario- Nuclear Medicine
Albert Driedger, MD, PhD
Role: STUDY_CHAIR
The University of Western Ontario - Nuclear Medicine
Joseph Chin, MD, PhD
Role: STUDY_DIRECTOR
The University of Western Ontario- Urology
Madeleine Moussa, MD
Role: STUDY_DIRECTOR
The University of Western Ontario - Pathology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital - Dpt. of Nuclear Medicine
London, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Weckermann D, Dorn R, Trefz M, Wagner T, Wawroschek F, Harzmann R. Sentinel lymph node dissection for prostate cancer: experience with more than 1,000 patients. J Urol. 2007 Mar;177(3):916-20. doi: 10.1016/j.juro.2006.10.074.
Corvin S, Schilling D, Eichhorn K, Hundt I, Hennenlotter J, Anastasiadis AG, Kuczyk M, Bares R, Stenzl A. Laparoscopic sentinel lymph node dissection--a novel technique for the staging of prostate cancer. Eur Urol. 2006 Feb;49(2):280-5. doi: 10.1016/j.eururo.2005.08.021. Epub 2005 Dec 9.
Kizu H, Takayama T, Fukuda M, Egawa M, Tsushima H, Yamada M, Ichiyanagi K, Yokoyama K, Onoguchi M, Tonami N. Fusion of SPECT and multidetector CT images for accurate localization of pelvic sentinel lymph nodes in prostate cancer patients. J Nucl Med Technol. 2005 Jun;33(2):78-82.
Schumacher MC, Burkhard FC, Thalmann GN, Fleischmann A, Studer UE. Is pelvic lymph node dissection necessary in patients with a serum PSA<10ng/ml undergoing radical prostatectomy for prostate cancer? Eur Urol. 2006 Aug;50(2):272-9. doi: 10.1016/j.eururo.2006.01.061. Epub 2006 Feb 28.
Weckermann D, Goppelt M, Dorn R, Wawroschek F, Harzmann R. Incidence of positive pelvic lymph nodes in patients with prostate cancer, a prostate-specific antigen (PSA) level of < or =10 ng/mL and biopsy Gleason score of < or =6, and their influence on PSA progression-free survival after radical prostatectomy. BJU Int. 2006 Jun;97(6):1173-8. doi: 10.1111/j.1464-410X.2006.06166.x.
Scardino P. Update: NCCN prostate cancer Clinical Practice Guidelines. J Natl Compr Canc Netw. 2005 Nov;3 Suppl 1:S29-33. No abstract available.
de Bonilla-Damia A, Roberto Brouwer O, Meinhardt W, Valdes-Olmos RA. Lymphatic drainage in prostate carcinoma assessed by lymphoscintigraphy and SPECT/CT: its importance for the sentinel node procedure. Rev Esp Med Nucl Imagen Mol. 2012 Mar-Apr;31(2):66-70. doi: 10.1016/j.remn.2011.09.003. Epub 2011 Nov 3.
Vermeeren L, Valdes Olmos RA, Meinhardt W, Bex A, van der Poel HG, Vogel WV, Sivro F, Hoefnagel CA, Horenblas S. Value of SPECT/CT for detection and anatomic localization of sentinel lymph nodes before laparoscopic sentinel node lymphadenectomy in prostate carcinoma. J Nucl Med. 2009 Jun;50(6):865-70. doi: 10.2967/jnumed.108.060673. Epub 2009 May 14.
Krengli M, Ballare A, Cannillo B, Rudoni M, Kocjancic E, Loi G, Brambilla M, Inglese E, Frea B. Potential advantage of studying the lymphatic drainage by sentinel node technique and SPECT-CT image fusion for pelvic irradiation of prostate cancer. Int J Radiat Oncol Biol Phys. 2006 Nov 15;66(4):1100-4. doi: 10.1016/j.ijrobp.2006.06.047. Epub 2006 Sep 11.
Rousseau C, Rousseau T, Bridji B, Pallardy A, Lacoste J, Campion L, Testard A, Aillet G, Mouaden A, Curtet C, Kraeber-Bodere F. Laparoscopic sentinel lymph node (SLN) versus extensive pelvic dissection for clinically localized prostate carcinoma. Eur J Nucl Med Mol Imaging. 2012 Feb;39(2):291-9. doi: 10.1007/s00259-011-1975-x. Epub 2011 Nov 16.
Related Links
Access external resources that provide additional context or updates about the study.
The University of Western Ontario
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
12638
Identifier Type: OTHER
Identifier Source: secondary_id
R-06-433
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.