Cervical CancerACRIN 6651NCT00004936
MRI and CT Scans to Evaluate Invasive Cervical Cancer Before Treating Patients
A study testing iodinated contrast dye, computed tomography and magnetic resonance imaging in people with Cervical Cancer, run by American College of Radiology Imaging Network at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- iodinated contrast dye, computed tomography and magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Apr 2000to Oct 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Morristown Memorial Hospital
Morristown, New Jersey, 07962-1956
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer
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.
Read the detailed description
OBJECTIVES:
- Compare the diagnostic performance of magnetic resonance imaging (MRI), computed tomography (CT), and clinical FIGO staging in patients with invasive cervical cancer.
- Compare the accuracy of MRI, CT, and clinical FIGO staging in the evaluation of morphologic tumor prognostic factors in FIGO stage IB1 and stage IB2 and greater in these patients.
- Examine the value of imaging assessment of tumor prognostic factors (alone or in combination) as predictors of recurrence within 2 years of surgery in these patients.
- Evaluate the quality of life in the 12-month period after staging and treatment to potentially change staging accuracy.
OUTLINE: This is a multicenter study.
Patients undergo a computed tomography scan with iodinated contrast dye followed by a magnetic resonance imaging scan with or without contrast comprising gadopentetate dimeglumine or vice versa.
Within 6 weeks of first protocol imaging study, patients undergo one of the following surgeries:
- Laparoscopic, transabdominal, or transvaginal hysterectomy
- Extrafascial total abdominal hysterectomy
- Trachelectomy Quality of life is assessed at 1 and 12 months.
Patients are followed every 3 months for 1 year and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 465 patients will be accrued for this study within 18 months.
- Conditions
- Cervical Cancer
- Being tested
- iodinated contrast dye, computed tomography, magnetic resonance imaging, gadopentetate dimeglumine
- 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
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iodinated contrast dyeDrug
computed tomographyProcedure or surgery
magnetic resonance imagingProcedure or surgery
gadopentetate dimeglumineRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 2000
- Primary completionMay 2001
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
Sponsor and investigators
- Lead sponsor
- American College of Radiology Imaging Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hedvig Hricak, MD, PhD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004936
- Sponsor's protocol ID
- CDR0000067622
- Other IDs
- ACRIN-6651, GOG-183, CA80098
- Acronym
- ACRIN 6651
- Status last verified
- Jan 2013
- First submitted
- 7 Mar 2000
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19019414Hricak 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.
PubMed 17940305Mitchell 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.
PubMed 17179104Amendola 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.
PubMed 16234512Hricak 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.
PubMed 16361632
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer
- ClinicalTrials.gov ID
- NCT00004936
- Acronym / sponsor ID
- ACRIN 6651 / CDR0000067622
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- American College of Radiology Imaging NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2000
- Primary completion
- May 2001 (actual)
- Study completion
- Oct 2002 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- Compare the diagnostic performance of magnetic resonance imaging (MRI), computed tomography (CT), and clinical FIGO staging in patients with invasive cervical cancer.
- Compare the accuracy of MRI, CT, and clinical FIGO staging in the evaluation of morphologic tumor prognostic factors in FIGO stage IB1 and stage IB2 and greater in these patients.
- Examine the value of imaging assessment of tumor prognostic factors (alone or in combination) as predictors of recurrence within 2 years of surgery in these patients.
- Evaluate the quality of life in the 12-month period after staging and treatment to potentially change staging accuracy.
OUTLINE: This is a multicenter study.
Patients undergo a computed tomography scan with iodinated contrast dye followed by a magnetic resonance imaging scan with or without contrast comprising gadopentetate dimeglumine or vice versa.
Within 6 weeks of first protocol imaging study, patients undergo one of the following surgeries:
- Laparoscopic, transabdominal, or transvaginal hysterectomy
- Extrafascial total abdominal hysterectomy
- Trachelectomy Quality of life is assessed at 1 and 12 months.
Patients are followed every 3 months for 1 year and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 465 patients will be accrued for this study within 18 months.
Study design
- Primary purpose
- Diagnosis
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iodinated contrast dye | Drug | – |
| computed tomography | Procedure or surgery | – |
| magnetic resonance imaging | Procedure or surgery | – |
| gadopentetate dimeglumine | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
- Results publication: PubMed 19019414Mitchell 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.
- Results publication: PubMed 17940305Hricak 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.
- Results publication: PubMed 17179104Mitchell 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.
- Results publication: PubMed 16234512Amendola 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.
- Results publication: PubMed 16361632Hricak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hedvig Hricak, MD, PhD study chair
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iodinated contrast dye, computed tomography and magnetic resonance imaging in people with Cervical Cancer, run by American College of Radiology Imaging Network at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004936, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2013.