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SPECT-CT Guided Lymphatic Mapping and Sentinel Lymphadenectomy (LM/SL) in Prostate Cancer

18 Years
Not Enrolling
Prostate Cancer

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Trial Information

SPECT-CT Guided Lymphatic Mapping and Sentinel Lymphadenectomy (LM/SL) in Prostate Cancer

A multidisciplinary team (urologist, oncologist, radiologist, pathologist, and nuclear
medicine) will assess the technical feasibility of LM/SL with SPECT/CT as well as its
clinical potential for the staging of regional lymph nodes in 30 consecutive patients with
AJCC stages I-II-III prostate cancer scheduled for prostatectomy and pelvic lymph node
dissection according to the standards of care.

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%).

Inclusion Criteria:

- Patients with histologically proven prostate cancer

- 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

- Informed consent signed by the patient

Exclusion Criteria:

- Patients with no histological evidence of prostate cancer

- Patient with regionally advanced disease or metastatic disease (T4, and/or N1, and/or

- Patients with clinically and/or radiologically evident regional lymph node metastases

- Patients who are not scheduled for radical prostatectomy and pelvic lymph node

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Technical feasibility and clinical utility of LM/SL with SPECT/CT in patients with early stage prostate cancer versus CLND.

Outcome Time Frame:

1 year - 2 years

Safety Issue:


Principal Investigator

Irina Rachinsky, MD, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Western Ontario- Nuclear Medicine


Canada: Ethics Review Committee

Study ID:




Start Date:

April 2008

Completion Date:

February 2012

Related Keywords:

  • Prostate Cancer
  • LM/SL
  • SPECT/low-dose multislice CT
  • Prostatic Neoplasms