MRI and CT Scans to Evaluate Invasive Cervical Cancer Before Treating Patients

NCT00004936 | Completed DMC

• 4 other identifiers: CDR0000067622ACRIN-6651GOG-183CA80098
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Imaging procedures such as MRI or CT scans may improve the ability to detect cervical cancer and determine the extent of disease. PURPOSE: Diagnostic trial to determine the effectiveness of MRI and CT scans in evaluating invasive cervical cancer before treatment of patients.

Conditions

Cervical Cancer

Keywords

stage III cervical cancer; stage IB cervical cancer; stage IIB cervical cancer; stage IVB cervical cancer; stage IIA cervical cancer; stage IVA cervical cancer; cervical squamous cell carcinoma; cervical adenocarcinoma; cervical adenosquamous cell carcinoma

Interventions

iodinated contrast dye DRUG

computed tomography PROCEDURE

magnetic resonance imaging PROCEDURE

gadopentetate dimeglumine RADIATION

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed invasive cervical cancer, including invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma * FIGO stage IB1 with clinically visible gross lesion OR * FIGO stage IB2 or greater * Scheduled for one of the following surgeries at a participating Gynecological Oncology Group center: * Laparoscopic, transabdominal, or transvaginal hysterectomy * Extrafascial total abdominal hysterectomy * Trachelectomy * Not scheduled for a loop electrosurgical excision procedure or a cone biopsy only PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No cardiac pacemakers Pulmonary: * No asthma Other: * Not pregnant * No contraindication to computed tomography (CT) (e.g., history of allergy to CT contrast medium) * No contraindication to magnetic resonance imaging (e.g., intracranial vascular clip) * No nonmalignant general medical or psychiatric condition that would preclude consent or surgery PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy for invasive cervical cancer Surgery: * See Disease Characteristics * No prior surgery for invasive cervical cancer Other: * No prior medical treatment for invasive cervical cancer

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• American College of Radiology Imaging Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Morristown Memorial Hospital

Morristown, New Jersey, 07962-1956, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (5)

• Mitchell DG, Snyder B, Coakley F, Reinhold C, Thomas G, Amendola MA, Schwartz LH, Woodward P, Pannu H, Atri M, Hricak H. Early invasive cervical cancer: MRI and CT predictors of lymphatic metastases in the ACRIN 6651/GOG 183 intergroup study. Gynecol Oncol. 2009 Jan;112(1):95-103. doi: 10.1016/j.ygyno.2008.10.005. Epub 2008 Nov 20.

  PMID: 19019414 RESULT

• Hricak H, Gatsonis C, Coakley FV, Snyder B, Reinhold C, Schwartz LH, Woodward PJ, Pannu HK, Amendola M, Mitchell DG. Early invasive cervical cancer: CT and MR imaging in preoperative evaluation - ACRIN/GOG comparative study of diagnostic performance and interobserver variability. Radiology. 2007 Nov;245(2):491-8. doi: 10.1148/radiol.2452061983.

  PMID: 17940305 RESULT

• Mitchell DG, Snyder B, Coakley F, Reinhold C, Thomas G, Amendola M, Schwartz LH, Woodward P, Pannu H, Hricak H. Early invasive cervical cancer: tumor delineation by magnetic resonance imaging, computed tomography, and clinical examination, verified by pathologic results, in the ACRIN 6651/GOG 183 Intergroup Study. J Clin Oncol. 2006 Dec 20;24(36):5687-94. doi: 10.1200/JCO.2006.07.4799.

  PMID: 17179104 RESULT

• Amendola MA, Hricak H, Mitchell DG, Snyder B, Chi DS, Long HJ 3rd, Fiorica JV, Gatsonis C. Utilization of diagnostic studies in the pretreatment evaluation of invasive cervical cancer in the United States: results of intergroup protocol ACRIN 6651/GOG 183. J Clin Oncol. 2005 Oct 20;23(30):7454-9. doi: 10.1200/JCO.2004.00.5397.

  PMID: 16234512 RESULT

• Hricak H, Gatsonis C, Chi DS, Amendola MA, Brandt K, Schwartz LH, Koelliker S, Siegelman ES, Brown JJ, McGhee RB Jr, Iyer R, Vitellas KM, Snyder B, Long HJ 3rd, Fiorica JV, Mitchell DG; American College of Radiology Imaging Network 6651; Gynecologic Oncology Group 183. Role of imaging in pretreatment evaluation of early invasive cervical cancer: results of the intergroup study American College of Radiology Imaging Network 6651-Gynecologic Oncology Group 183. J Clin Oncol. 2005 Dec 20;23(36):9329-37. doi: 10.1200/JCO.2005.02.0354.

  PMID: 16361632 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Magnetic Resonance Spectroscopy; Gadolinium DTPA

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Pentetic Acid; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Coordination Complexes

Study Officials

• Hedvig Hricak, MD, PhD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: DIAGNOSTIC
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2000
• First Posted: January 27, 2003
• Study Start: April 1, 2000
• Primary Completion: May 1, 2001
• Study Completion: October 1, 2002
• Last Updated: January 28, 2013

Record last verified: 2013-01

Locations

US (2)