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First Open Trial of the American College of Radiology Imaging Network: Proper Imaging Approach for Invasive Cervical Cancer¹

¹ From the Department of Radiology, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, C-278, New York, NY 10021. Received June 14, 2002; accepted June 17. Address correspondence to the author.

Index terms: Editorials • Radiology and radiologists, research

The American College of Radiology Imaging Network (ACRIN) is a National Cancer Institute (NCI)-funded cooperative group dedicated to conducting multidisciplinary multicenter clinical trials of diagnostic imaging and image-guided therapeutic technologies. In December 1999, ACRIN opened its first trial to patient accrual in collaboration with the long-standing Gynecology Oncology Group, "ACRIN 6651, Role of Radiology in the Pre-treatment Evaluation of Invasive Cervical Cancer" (hereafter, ACRIN 6651). In this edition of a continuing series of Radiology editorials about ACRIN, as the principal investigator of ACRIN 6651, I would like to detail my experiences and the lessons learned (1).

ACRIN 6651 represents a consortium of the nation’s premier institutions, radiologists, and clinicians working together to identify the role of imaging in the pretreatment evaluation of invasive cervical cancer. This prospective trial, first brought to ACRIN as a concept in February 1999, is filled with motivation, challenges, lessons learned, and aspirations for the future.

The protocol for ACRIN 6651 focuses on the diagnostic work-up for invasive cervical cancer. Currently, recommendations for the diagnostic evaluation of tumor staging follow the clinical International Federation of Gynecology & Obstetrics (FIGO) staging guidelines, which are based on findings from physical examination, colposcopy, lesion biopsy, chest radiography, cystoscopy, sigmoidoscopy, intravenous urography, and barium enema study. This study then compares clinical FIGO staging to pretreatment evaluation with computed tomography (CT) and/or magnetic resonance (MR) imaging in order to establish the most accurate pretreatment staging and assessment of morphologic tumor prognostic factors, a pathway to decreased utilization of invasive tests and, last, to design algorithms, which consider both the benefits and the costs of pretreatment evaluation of cervical cancer.

By and large, the value of CT and MR imaging to evaluate tumor staging for cervical cancer has not yet been widely accepted. That there are numerous gaps in the literature was the motivation to conduct a multicenter clinical trial in this area. In addition, patient preference about diagnostic work-up is also being examined for the first time. The results of the study will be disseminated by means of traditional peer-reviewed publications and presentations, as well as public relations vehicles of ACRIN, the Gynecology Oncology Group, and the NCI.

Being the principal investigator of the first ACRIN consortium trial to open is a great honor and privilege. It offers a tremendous opportunity to explore the great unknown and return with hopefully valuable information that will affect how we, as physicians, practice radiology and medicine in relation to cancer care. The radiology community is collaborating on a multidisciplinary multiinstitutional research project to build consensus on how we "see" and how we "interpret" pretreatment evaluation of cervical cancer. The effect of this trial, however, goes beyond the initial trial itself. This collaborative project can, in effect, ignite a cultural change—promoting the use of radiology consortia for investigations of cancer care as has occurred only rarely in the past. Thus, the potential is there to (a) encourage other cooperative clinical trials that can improve clinical practice, (b) bring together well-regarded researchers and community and academic practitioners, (c) provide experience in the conduct of rigorous clinical trials for radiology researchers who otherwise would not have this opportunity, and (d) conduct multidisciplinary multiinstitutional clinical research that provides more compelling, more dependable, more generalizable, and more comprehensive studies than are possible with single-institution studies. The outcomes of these justifications are ultimately to develop more partnerships, to build consensus, and most important, to establish an evidence basis that will lead to better diagnostic algorithms for cancer care.

This pioneering experience, however, does not come without its challenges! Working with a consortium has its own special dynamic that requires time, patience, flexibility, and communication.

For the past 3 years, there has been great enthusiasm for joining the cervix trial. To date, 23 institutions joined the consortium and enrolled 171 patients. However, performance is sometimes slower than its "partner" enthusiasm. Since the trial began, several factors have influenced its slow but steady progression. Since this is the first ACRIN clinical trial, time was needed to iron out logistic kinks (administrative details such as forms, scheduling of conference calls, etc); we have also been challenged to work as an interdisciplinary group and confront different institutional modes of operation; there was a need for three amendments to the study since it began; there is much variation in the levels of expertise among the research assistants who are assigned to the trial; and commitment and understanding of a cooperative trial varies among the radiologists as well. Furthermore, we are faced with the fact that medicine is a dynamic science of uncertainty.

Since 1999, treatment guidelines and trends in the management of cervical cancer have changed. In the past 3 years, the use of invasive surgery in the treatment of cervical cancer has declined and been replaced by chemotherapy and radiation therapy. Consequently, this has led to a diminished pool of eligible patients for our study and ultimately requires a longer time to reach the projected patient accrual. There were other challenges along the way, such as learning how to live together, establishing new guidelines, and understanding how site auditing is different for imaging studies than for therapeutic ones, reinforcing that communication at all levels is the essence of success in any cooperative trial. These may seem trivial, but at times they present crucial challenges.

The logistics of conducting an ACRIN trial are a responsibility of ACRIN; however, as the first open trial, the protocol for ACRIN 6651 was forging new ground. The investigators had to learn how to optimize communications among the ACRIN headquarters administration in Philadelphia, Pa; the Biostatistical Center in Providence, RI; and among the far-flung research assistants, gynecologists, and radiologists at the patient accrual sites. Making sure that the radiologist-site principal investigators on the study were indeed involved despite the ever increasing demand on the radiologists’ clinical time proved a potent challenge. Amendments to the protocol were required as it became obvious that some of the initial specific aims and guidelines were not detailed enough. Other amendments were required by the change in medical practice. Understanding that to live with change is the way of life became our motto. The hopes and the disappointments of patient accrual were at times disheartening, but at the end it all came into place.

However, the advantages of participating in an ACRIN trial far outweigh any of the challenges. Being a part of this consortium has enabled us, as cancer researchers and clinicians, to pull together our knowledge. The national alliance enables us to accomplish tasks at our own institutions that previously may not have been considered or agreed to, and we are accumulating national data that include a broader range of patients. In addition, it is a wonderful experience to work with a very enthusiastic group of colleagues and with ACRIN and the NCI. With the establishment of this ACRIN trial, we are creating a special voice that the medical community respects and desires to listen to. We are building new partnerships and establishing consensus regarding the role of radiology in the pretreatment evaluation of invasive cervical cancer care. Finally, we are teaching our organizations, the medical community, and ourselves to learn to live with change.

The radiologic consortium initiatives that ACRIN is pioneering to advance knowledge in the treatment and management of cancer are the future for developing better cancer care protocols. Join ACRIN trials and follow a path that will allow you to take some new footsteps along the way!

REFERENCES

1. Hillman BJ. The American College of Radiology Imaging Network and the mission of radiologists (editorial). Radiology 2002; 223:602.[Free Full Text]

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