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Editorials |
1 From the Research Offices of the American College of Radiology, Philadelphia, Pa, and Department of Radiology, University of Virginia Health System, PO Box 800170, Charlottesville, VA 22908. Received March 21, 2002; accepted April 1. Address correspondence to the author (e-mail: bjh8a@virginia.edu).
Index terms: Editorials • Radiology and radiologists, research
The American College of Radiology Imaging Network (ACRIN) is one of 13 National Cancer Institute (NCI)-funded cooperative groups that conduct multiinstitutional clinical trials related to cancer and the only group that focuses on trials of medical imaging technologies. To that end, ACRIN has developed an infrastructure and committees to work with individual investigators and institutions to make clinical trials possible (1).
Since March 1999, ACRIN has been developing its clinical trials portfolio. Ideas for trials have emerged from independent investigators, the 12 ACRIN scientific committees, the NCI therapeutic cooperative groups, and ACRIN leadership. Trial ideas may be submitted to ACRIN in abbreviated format, without budgets or statistics (details available at www.acrin .org). If ACRIN decides to pursue the trial, the individual submitting the idea becomes the principal investigator of the trial and works with ACRIN Headquarters and Biostatistical and Data Management Center to put together a comprehensive trial team to fully develop and implement the protocol.
In determining which trials to pursue, ACRIN has considered a number of factors. Most significant is the "importance" of the disease and the technology to be studied—for example, cancer prevalence and morbidity and mortality, and the potential of the technology to change the course and outcome of cancer. In addition, ACRIN leadership has tried to balance trials of exciting emerging technologies with those of established practices that might be questionable. ACRIN has developed or is in the process of developing trials to evaluate diagnostic, image-guided therapeutic, and screening technologies, as well as technologies that hold promise as potential early markers for the success of therapy.
By March 2002, ACRIN had initiated 14 trials, and there were five others that it was considering in the context of its budget. What follows are brief descriptions of these trials. I have listed the principal investigators and their institutions so that the reader can appreciate the geographic scope of the endeavor. Subsequent editorials about ACRIN will provide more detail about some of these trials.
1. Magnetic resonance (MR) versus computed tomography (CT) of the cervix. Directed by Hedvig Hricak, MD, PhD, of Memorial Sloan-Kettering Cancer Center (New York, NY). This trial compares the accuracy of CT and MR in staging cervical cancer, primarily to determine which modality better categorizes patients as being amenable to surgical treatment. ACRIN is collaborating with the Gynecology Oncology Group— an NCI therapeutic cooperative group— to facilitate patient recruitment. This was the first ACRIN trial to open, and more than 140 patients have been recruited at more than 15 sites. The trial remains open.
2. Retrospective evaluation of the accuracy of CT colonography. This trial, led by C. Daniel Johnson, MD, of the Mayo Clinic (Rochester, Minn), resulted from the collection of colonography cases with traditional colonoscopy follow-up at multiple institutions. Eighteen readers with varying experience read the more than 90 cases in the American College of Radiology Research Offices in Philadelphia, Pa, which serves as the ACRIN headquarters. The trial is closed, the results are undergoing final analysis, and a manuscript—the first from ACRIN—should be submitted soon. The results of this retrospective trial were sufficiently positive that a larger prospective trial, also led by Dr Johnson, is now in development.
3. Digital versus conventional mammography for breast cancer screening. The principal investigator for this trial of 49,500 women is Etta Pisano, MD, of the University of North Carolina (Chapel Hill). All patients will undergo both tests. The primary emphasis is on diagnostic accuracy; however, a creative experimental design will also allow a comparison of quality of life and costs. This trial is now open and is scheduled to accrue at least six patients per day at each of 19 sites.
4. Chemoembolization plus conventional chemotherapy versus conventional chemotherapy alone for local control of hepatic metastases from colorectal cancer. The principal investigator is Michael Soulen, MD, of the University of Pennsylvania (Philadelphia). The first phase of this trial has opened and is a toxicity study to determine the proper dose for chemoembolization. This will be followed by a phase III trial involving several hundred patients that ACRIN hopes to open in 2003.
5. Reader agreement regarding CT volume as a prognostic indicator for supraglottic cancers. Directed by Suresh Mukherji, MD, of the University of Michigan (Ann Arbor), this trial is a retrospective sample of 20 CT studies in patients with supraglottic cancers from an earlier Radiation Therapy Oncology Group (RTOG) study. Multiple readers will measure the lesions volumetrically to determine interreader variation. Should variation among readers be small, a prospective trial to evaluate the technique against outcome would follow. Case collection for this retrospective trial is now closed, and readers will be assembled shortly.
6. Radio-frequency ablation of bone metastases to alleviate intractable pain. Directed by Damien Dupuey, MD, of Brown University (Providence, RI), this trial will prospectively evaluate the palliative effect of this technology. The trial is conducted with a validated pain scale and a diary of pain medicine use to evaluate efficacy. As of March 2000, the trial was open at one site with several other sites expected to join the trial shortly.
7. CT screening for lung cancer. Under the direction of Denise Aberle, MD (University of California, Los Angeles [UCLA]), ACRIN is collaborating with the NCI Lung Screening Study to conduct a randomized trial with 50,000 individuals at high risk of developing lung cancer, to determine whether CT screening reduces lung cancer–specific mortality. In addition to the central question, ACRIN also will study the effect of screening on quality of life and chart associated costs. Participant recruitment will take place at as many as 20 sites nationally. Some of these sites also will collect urine, blood, and sputum specimens to store for future biomarkers research. This trial is expected to open in the summer of 2002.
8. Dynamic MR imaging of advanced breast cancer. This trial, directed by Nola Hylton, PhD, of the University of California San Francisco, seeks to assess the potential of tumor enhancement followed by MR imaging as an early predictor of the success of therapy in patients with advanced breast cancer. The trial is restricted to a small number of sites that have experience with the technique and that are also members of the Cancer and Leukemia Group B cooperative group, with which ACRIN is collaborating. This trial is now open to participant accrual.
9. Positron emission tomography (PET) as an early marker of the success of imatinib mesylate (Gleevec; Novartis Pharmaceuticals, East Hanover, NJ) in treating gastrointestinal stromal tumors. Annick van den Abbeele, MD, of the Dana Farber Cancer Center (Boston, Mass) leads this collaboration with RTOG. The trial is open to sites that are RTOG members and that will recruit the participants. Sequential PET and CT imaging will be tested as a means of determining as early as possible whether imatinib mesylate is having a positive effect upon the tumors. This trial is now open.
10. MR imaging and MR spectroscopic imaging to stage prostate cancer. Jeffrey Weinreb, MD, of New York University, leads this pilot trial of new software to investigate the potential of MR spectroscopic imaging to help better categorize patients as likely to benefit from surgical therapy for prostate cancer. The protocol has passed regulatory approval and will begin shortly at a small number of select sites that have experience with this technique. GE Medical Systems (Milwaukee, Wis) is supplying the software and other support for the trial.
11. Multimodality staging of pediatric solid tumors. Led by Marilyn Siegel, MD, of Washington University (St Louis, Mo), this trial seeks to define the optimal work-up for pediatric patients with solid tumors. The trial will involve approximately 20 sites that have participated in protocol development. Patients will be recruited by oncologists and referred to the participating radiologists for imaging. This trial is awaiting regulatory approval.
12. Semiautomated segmentation of glioblastoma. The principal investigator of this trial is Birgit Ertl-Wagner, MD, PhD, of the University of Munich (Germany). Dr Ertl-Wagner was an ACR-RSNA Fellow in Clinical Trials, working with ACRIN during the 2001–2002 academic year. She proved herself accomplished enough to become an ACRIN principal investigator and to lead this trial comparing two software modules developed at the Henry Ford Health System (Detroit, Mich) and the University of Pennsylvania (Philadelphia). The goal is to apply the software to the measurement of viable tumor on retrospectively acquired MR images in glioblastoma patients. This trial is awaiting regulatory approval.
13. Radio-frequency ablation of hepatic tumors. Gerald Dodd III, MD, of the University of Texas San Antonio is the principal investigator of a trial that will evaluate radio-frequency ablation for local control of hepatic tumors. Hepatomas and metastases from colorectal cancer will be assessed separately in the two arms of the trial. This trial received suggestions for improvement from the Cancer Therapy Evaluation Group, which approves all cooperative group trials before they are implemented, and is in revision.
Although some of these trials are restricted to a certain number of participating institutions because of the high infrastructural costs associated with the trials, the general rule for how ACRIN operates is to be inclusive. Most of the ACRIN trials described in this article welcome the participation of all institutions that have the technology and personnel required for the specific trial. ACRIN assists participating sites by providing partial funding to support a research associate and by paying a per case reimbursement for each patient accrued by the site. ACRIN wishes to involve all of radiology in its efforts, including both community and academic practices. General qualifying applications for institutions can be found on the ACRIN web site (www .acrin.org). I welcome inquiries from radiologists about how their institutions could participate in ACRIN trials and from those interested in submitting an idea for consideration of becoming an ACRIN trial.
REFERENCES
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