The Role of Functional MRI and Doppler Sonography in Assessing Blood Vessel Formation Within the Tumors of Endometrial Cancer Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2004 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00166985
First received: September 12, 2005
Last updated: December 26, 2006
Last verified: August 2004
  Purpose

Adenocarcinoma of the endometrium is the fourth most frequent cancer in women. Surgery is the treatment of choice in patients with noninvasive or locally advanced disease. The surgical technique consists of an exploratory laparotomy, with total hysterectomy, bilateral oophorectomy, peritoneal washing, and, in selected high-risk patients, omental and peritoneal biopsies and lymphadenectomy. Therefore, preoperative clinical and instrumental staging of the local spread of disease, as well as local and distant lymph node involvement, represent a critical step in tailoring the extent and the radicalness of surgery.

The role of angiogenesis in cancer growth and metastasis has been gaining much attention for decades. Recent clinical evidence supports this notion. The gradual increase in angiogenesis intensity with tumor progression in malignant melanoma has been reported. Abulafia et al. reported that increasing angiogenicity could be noted from simple hyperplasia, complex hyperplasia, atypical hyperplasia, and Stage IA endometrial carcinoma to invasive endometrial carcinoma. The investigators' research team has shown that incremental angiogenesis could be demonstrated in the tumorigenesis and the possibility of lymph node metastasis in endometrial malignancy. Besides, other growth factors such as vascular endothelial growth factor (VEGF), transforming growth factor- (TGF-), IL-6 and IL-8 have also been reported to correlate with the angiogenesis and the metastasis of endometrial cancer. It seems that tumor angiogenesis of endometrial cancer could be utilized as an important parameter to assess the disease severity of the endometrial cancer.

So, the investigators would like to propose this proposal to focus on the tumor angiogenesis in endometrial cancer patients. There are several purposes in this study. First, the investigators will evaluate and compare tumor angiogenesis surveyed from functional MRI and power Doppler sonography in endometrial cancer patients who receive surgery. Second, the investigators will evaluate whether tumor angiogenesis could be a marker to predict the disease severity of endometrial cancer. Third, the role of functional magnetic resonance imaging (MRI) in endometrial cancer will be elucidated.


Condition
Endometrial Cancer

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: The Role of Functional MRI and Doppler Sonography in Assessing Intratumoral Angiogenesis of Endometrial Cancer Patients

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Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 200
Study Start Date: September 2004
Estimated Study Completion Date: December 2008
Detailed Description:

Adenocarcinoma of the endometrium is the fourth most frequent cancer in women. Surgery is the treatment of choice in patients with noninvasive or locally advanced disease. The surgical technique consists of an exploratory laparotomy, with total hysterectomy, bilateral oophorectomy, peritoneal washing, and, in selected high-risk patients, omental and peritoneal biopsies and lymphadenectomy. Therefore, preoperative clinical and instrumental staging of the local spread of disease, as well as local and distant lymph node involvement, represent a critical step in tailoring the extent and the radicalness of surgery.

The role of angiogenesis in cancer growth and metastasis has been gaining much attention for decades. Recent clinical evidence supports this notion. The gradual increase in angiogenesis intensity with tumor progression in malignant melanoma has been reported. Abulafia et al. observed that increasing angiogenicity from simple hyperplasia, complex hyperplasia, atypical hyperplasia, and Stage IA endometrial carcinoma to invasive endometrial carcinoma has been found by histopathologic examination. Several articles have reported that transvaginal color and pulse Doppler ultrasound may be helpful blood in the evaluation of various gynecologic tumors. Besides, our previous studies have also shown that incremental angiogenesis could be demonstrated in the tumorigenesis and the possibility of lymph node metastasis in endometrial malignancy. Other growth factors such as vascular endothelial growth factor (VEGF), TGF-, IL-6, and IL-8 have also been reported to correlate with the angiogenesis and the metastasis of endometrial cancer. It seems that tumor angiogenesis of endometrial cancer could be utilized as an important parameter to assess the disease severity of the endometrial cancer.

Determining microvessel density is regarded as a standard procedure to quantitate tumor angiogenesis. However, microvessel density always has been assessed retrospectively and in vitro. Preoperative prediction of the microvessel density would be of value clinically for evaluating severity and progression of disease.

So, we would like to propose this proposal to focus on the tumor angiogenesis in endometrial cancer patients. Endometrial cancer patients who will receive staging surgery will be enrolled in this study. Functional MRI, and transvaginal sonography will be undergone before the surgery in each patient. The angiogenesis-related growth factors will be evaluated later from the surgical specimens. The clinical pathologic items, various angiogenic parameters obtained from the MRI and sonography, and angiogenesis-related factors will be compared and correlated together. There are several purposes in this study. First, we will evaluate and compare tumor angiogenesis surveyed from functional MRI and power Doppler sonography in endometrial cancer patients who receive surgery. Second, we will evaluate whether tumor angiogenesis could be a marker to predict the disease severity of endometrial cancer. Third, we will elucidate the role of functional MRI in endometrial cancer.

Endometrial cancer patients with histopathologic proof who are arranged to receive staging surgery are eligible. All patients will undergo surgery, including total abdominal hysterectomy, bilateral salpingo-oophorectomy, and pelvic and/or para-aortic lymph node dissection or sampling. Surgical specimens will be evaluated for tumor size, histologic grading, depth of myometrial invasion, and presence of lymphovascular emboli and lymph node metastasis. Stage will be determined using the International Federation of Gynecology and Obstetrics classification. Tumors of histologic types other than adenocarcinoma and adenoacanthoma will be excluded. The carcinomas were classified using a three-grade system: grade 1 carcinomas showed glandular formation in more than 95% of the tumor, grade 2 carcinomas showed a solid growth pattern in 5-50%, and grade 3 carcinomas showed a solid pattern in more than 50%. All of the patients who will be enrolled into this study need to sign the consent form and the study protocol will be under the approval of the Institutional Review Board of the patient's hospital.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Endometrial cancer patients with histopathologic proof who are arranged to receive staging surgery.
  • All of the patients who will be enrolled into this study need to sign the consent form and the study protocol will be under the approval of the Institutional Review Board of the patient's hospital.

Exclusion Criteria:

  • Tumors of histologic types other than adenocarcinoma and adenoacanthoma will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166985

Contacts
Contact: Chi-An Chen, MD 886-2-2312-3456 ext 5157 cachen@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Chi-An Chen, MD    886-2-2312-3456 ext 5157    cachen@ha.mc.ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chi-An Chen, MD National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00166985     History of Changes
Other Study ID Numbers: 9361701182
Study First Received: September 12, 2005
Last Updated: December 26, 2006
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
endometrial cancer, MRI, Doppler sonography, angiogenesis

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 26, 2014