Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Patients in experimental arm will go through additional preoperative staging with contrast enhanced mammography

Patients in No intervention arm will go through no additional preoperative imaging

Contrast Enhanced Mammography (CEM)

Kristina Ahsberg, PhD

Patients diagnosed with breast cancer after routine assessment with digital mammography and ultrasound and scheduled for primary surgery are included in the trial. The patients are randomized 1:1 to go through additional contrast enhanced mammography (CEM) or no further imaging preoperatively. Primary endpoint is rate of patients with change of treatment: a) mastectomy instead of partial mastectomy due larger unifocal or multifocal extent, b) partial mastectomy instead of mastectomy due to improved demarcation of the tumour area, c) bilateral surgery instead of unilateral due to findings of contralateral cancer, d) neoadjuvant therapy instead of primary surgery due to more advanced disease. Rate of reoperation and rate of avoidable mastectomies are secondary endpoints.

Breast cancer is very uncommon among men.

Added Value of Preoperative Contrast Enhanced Mammography in Staging of Malignant Breast Lesions

Added Value of Preoperative Contrast Enhanced Mammography (PROCEM) in Staging of Malignant Breast Lesions - a Prospective Randomized Multicenter Trial

Mastectomy instead of partial mastectomy due to findings of multifocal disease, mastectomy instead of partial mastectomy due to larger unifocal extent, partial mastectomy instead of mastectomy due to improved demarcation of tumour area, bilateral surgery due to findings of contralateral cancer, primary neoadjuvant treatment instead of primary surgery due to more advanced disease

Number of reoperations due to inadequate margins

Patients operated with mastectomy where histopathology shows extent less than 3 cm

Region Halland

Symptoms and General Pathology

Digestive System Diseases

Behaviors and Mental Disorders

Rare Diseases

Inflammation

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Quality of Life

Stomach Cancer

Acute Graft Versus Host Disease

laparoscopy-assisted distal gastrectomy

open distal gastrectomy

Hyung-Ho Kim, MD, PhD

Chan Young Kim, MD

Sang Il Lee, MD

Sang IL Lee, MD

Gyu Seok Cho, MD, PhD

Wook Kim, MD, PhD

Seung-Wan Ryu, MD, PhD

Min Chan Kim, MD, PhD

Do Joong Park, MD

Hyuk-Joon Lee, MD, PhD

Han Kwang Yang, MD, PhD

Woo Jin Hyung, MD, PhD

Kyo Young Song, MD, PhD

Joo Ho Lee, MD

Seung Ho Choi, MD

Tae Sung Sohn, MD

Sang-Uk Han, MD, PhD

Hyung Min Jin, MD

Kyu Yeol Kim, MD

The purpose of this study is to assess the usefulness of laparoscopic surgery for gastric cancer in comparison with open gastrectomy.

Recently, in technical aspects, almost all kinds of open gastric cancer surgeries can be reproduced laparoscopically. However, many controversies exist due to no evidence and no long-term results. There was no prospective multi-center large-scale randomized controlled trial in the world on the long-term outcome of laparoscopic gastric cancer surgery.

Korean Laparoscopic Gastrointestinal Surgery Study Group, therefore, proposed a multi-institutional prospective randomized trial on comparing laparoscopy-assisted versus open distal gastrectomy for gastric cancer (KLASS Trial) after the feasibility and validity of these procedures had been evaluated by analyzing retrospective multi-center large series.

This KLASS trial is supported by a grant for 2005 from the National R\&D Program for Cancer Control, Ministry of Health \& Welfare, Republic of Korea. Nine surgeons from 9 centers are participating in this trial. All the participants performed more than 50 cases of open and laparoscopic gastrectomies, respectively and their institutes had more than 80 cases of gastric cancer surgeries per year. Primary endpoint of this trial is to elucidate that there is no difference of overall and disease-free survivals between laparoscopic and open groups. The KLASS trial consists of 5 major subjects: comparison of 5-year overall and disease-free survivals, standardization of preoperative diagnosis, assessment of the quality of life, evaluation of postoperative inflammatory response and immune function, and cost-effectiveness. The KLASS trial will be able to validate and verify laparoscopic gastric cancer surgery.

Comparison of Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Prospective Randomized Trial

Multi-institutional Prospective Randomized Trial on the Assessment of Laparoscopic Surgery for Gastric Cancer

National Cancer Center, Korea

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Preoperative MRI

Erik Rud, MD

The investigators want to evaluate if preoperative MRI improves the surgical results, especially in respect to surgical margins. The impact on the surgical procedure will be evaluated.

In addition the investigators will examine the accuracy of tumor detection, localization and staging.

Background:

During the last two decades, Magnetic Resonance Imaging (MRI) of the prostate has evolved to become a promising tool in preoperative evaluation of prostate cancer. Several studies have evaluated the radiological and histopathological correlation. However, the sensitivity and specificity in regard to staging have shown wide ranges and poor reproducibility. These discrepancies can be explained by difference in patient selection, MRI methods, and criteria used for diagnosis. More studies are therefore needed to evaluate the clinical impact of preoperative MRI in patients with prostate cancer.

Aims of the study:

To evaluate 1) detection rate of tumor 1-3 (tumor 1 = index tumor), size of tumor 1-3, possible extraprostatic extension and predict presence of Gleason grade 4 and 5 tumor, 2) the influence of preoperative MRI on the surgical decision process with respect to the operative procedure for removal of the gland and pelvic lymph node dissection, and 3) the impact of preoperative MRI on the rate of positive surgical margins and functional results.

Material and method:

A prospective study including 400 consecutive patients referred to robot assisted laparoscopic prostatectomy randomised to preoperative MRI (intervention group) and no MRI (control group). The prostatectomy specimens will be histopathologically examined, and TNM classification will be performed according to 2002 AJCC standard.

Preoperative Magnetic Resonance (MR) Imaging of Prostate Cancer

Clinical Impact of MR Imaging in Patients With Prostate Cancer

The surgical margins are assessed by evaluating the pathological specimen

Evaluate the functional outcome in respect to erectile dysfunction.

Oslo University Hospital

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Milena Cerny, Resident

Sabine Schmidt Kobbe, MER

Milena Cerny

Sabine Schmidt Kobbe, Dr.

The purpose of this study is to determine whether whole-body MRI (WB-MRI) accuracy is superior to FDG-PET-CT considered as the gold-standard for the staging of distant lesions of rectal cancer.

Rectal cancer is the second cause of mortality after lung cancer in industrialized countries and represent 28% of colorectal carcinomas. Despite major improvements in diagnosis and treatment made those last years,mortality and morbidity remains high, because of high prevalence of metastasis and local recurrence. A accurate initial staging is of paramount importance for an appropriate treatment (neoadjuvant chemiotherapy and radiotherapy, surgery).

Actually, there is no international consensus concerning imaging for the staging of rectal cancer and modalities used are variable from one center to another.

WB-MRI represented a attractive and promising technique for the staging of rectal cancer, free of ionizing radiation .

Diagnostic Value of Whole-Body MRI for Rectal Cancer Preoperative Staging

Diagnostic Value of Whole-Body MRI Compared to FDG-PET-CT for Rectal Cancer Preoperative Staging, Before and After Neoadjuvant Treatment

We will compare for each body region the findings of the whole-body MRI to the FDG-PET-CT considered as the gold-standard and measure sensibility/specificity and diagnostic accuracy of the whole-body MRI for distant lesions of rectal cancer.

Evaluate the tumoral regression after neoadjuvant treatment on the MRI by the measurement of the ADC (attenuation diffusion coefficient) increase and compare the results to the measure of the SUV (standard uptake value) decrease on the FDG-PET-CT.

University of Lausanne Hospitals

Dr. Milena Cerny

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Added Value of Preoperative Contrast Enhanced Mammography in Staging of Malignant Breast Lesions	NCT04437602	Breast Cancer	Contrast Enhanc...	18 Years -	Region Halland
Comparison of Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Prospective Randomized Trial	NCT00452751	Gastric Cancer	laparoscopy-ass... open distal gas...	20 Years - 80 Years	National Cancer Center, Korea
Preoperative Magnetic Resonance (MR) Imaging of Prostate Cancer	NCT01347320	Prostate Cancer	Preoperative MR...	18 Years -	Oslo University Hospital
Diagnostic Value of Whole-Body MRI for Rectal Cancer Preoperative Staging	NCT01745874	Rectal Cancer		18 Years - 95 Years	University of Lausanne Hospitals
Comparison of Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Prospective Randomized Trial	NCT00452751	Gastric Cancer	laparoscopy-ass... open distal gas...	20 Years - 80 Years	National Cancer Center, Korea

Spots Global Cancer Trial Database for preoperative staging