[<sup>18</sup>F]Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET)/Computed Tomography (CT) in Suspected Recurrent Breast Cancer: A Prospective Comparative Study of Dual-Time-Point FDG-PET/CT, Contrast-Enhanced CT, and Bone Scintigraphy

Hildebrandt, Malene Grubbe; Gerke, Oke; Baun, Christina; Falch, Kirsten; Hansen, Jeanette Ansholm; Farahani, Ziba Ahangarani; Petersen, Henrik; Larsen, Lisbeth Aagaard; Duvnjak, Sandra; Buskevica, Inguna; Bektas, Selma; Søe, Katrine Lydolph; Jylling, Anne Marie Bak; Ewertz, Marianne; Alavi, Abass; Høilund‐Carlsen, Poul Flemming

doi:10.1200/jco.2015.63.5185

Cited by 78 publications

(79 citation statements)

References 33 publications

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“…Measurements of glucose metabolism by FDG PET/CT have a high degree of repeatability [6] and show less inter-observer variability than measurements of tumor size [7]. PET/CT can differentiate active tumor from post-therapeutic changes and assess metabolic activity in osseous metastases [8]. Changes in FDG uptake have demonstrated a high accuracy for predicting histopathologic response of breast cancer in the neoadjuvant setting [9–11] and appears superior when compared to size measurements alone [12].…”

Section: Introductionmentioning

confidence: 99%

Comparison of FDG-PET/CT and contrast-enhanced CT for monitoring therapy response in patients with metastatic breast cancer

Riedl

Pinker

Ulaner

et al. 2017

Eur J Nucl Med Mol Imaging

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Purpose The aim of this study was to compare fluorodeoxyglucose positron emission tomography (FDG PET/CT) and contrast-enhanced computed tomography (CE-CT) for the prediction of progression-free survival (PFS) and disease-specific survival (DSS) in patients with stage IV breast cancer undergoing systemic therapy. Methods Sixty-five patients with metastatic breast cancer treated with first- or second-line systemic therapy in prospective clinical trials were included. Response to treatment was evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for CE-CT and by PET response criteria in solid tumors (PERCIST), respectively. Results All responders by RECIST (n=22) were also responders by PERCIST, but 40% (17/43) of non-responders by RECIST were responders by PERCIST. Responses according to RECIST and PERCIST both correlated with PFS, but PERCIST showed a significantly higher predictive accuracy (concordance index for PFS: 0.70 vs. 0.60). One-year PFS for responders vs. non-responders by RECIST was 59% vs. 27%, compared to 63% vs. 0% by PERCIST. Four-year DSS of responders and non-responders by RECIST were 50% and 38%, respectively (p=0.2, concordance index: 0.55) as compared to 58% vs. 18% for PERCIST (p<0.001, concordance index: 0.65). Response on PET/CT was also a significantly better predictor for DSS than disease control on CE-CT. Conclusions In patients with metastatic breast cancer, tumor response on PET/CT appears to be a superior predictor of PFS and DSS than response on CE-CT. Monitoring tumor response by PET/CT may increase the power of clinical trials using tumor response as an endpoint, and may improve patient management in clinical routine.

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Section: Introductionmentioning

confidence: 99%

Comparison of FDG-PET/CT and contrast-enhanced CT for monitoring therapy response in patients with metastatic breast cancer

Riedl

Pinker

Ulaner

et al. 2017

Eur J Nucl Med Mol Imaging

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“…Group-sequential designs can likewise be easily implemented in other settings than agreement studies. We investigated the diagnostic accuracy of FDG-PET/CT with dual time point imaging (60 and 180 min), contrast-enhanced CT, and bone scintigraphy in patients with suspected breast cancer recurrence previously in a prospective study [ 17 ]. Testing the global hypothesis on equality of the areas under the ROC curves was performed once at the end of the study ( N = 100) but could as well have served as primary hypothesis for interim analyses with, for instance, one half or one third and two third of the sample size.…”

Section: Discussionmentioning

confidence: 99%

Group-sequential analysis may allow for early trial termination: illustration by an intra-observer repeatability study

et al. 2017

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BackgroundGroup-sequential testing is widely used in pivotal therapeutic, but rarely in diagnostic research, although it may save studies, time, and costs. The purpose of this paper was to demonstrate a group-sequential analysis strategy in an intra-observer study on quantitative FDG-PET/CT measurements, illuminating the possibility of early trial termination which implicates significant potential time and resource savings.MethodsPrimary lesion maximum standardised uptake value (SUVmax) was determined twice from preoperative FDG-PET/CTs in 45 ovarian cancer patients. Differences in SUVmax were assumed to be normally distributed, and sequential one-sided hypothesis tests on the population standard deviation of the differences against a hypothesised value of 1.5 were performed, employing an alpha spending function. The fixed-sample analysis (N = 45) was compared with the group-sequential analysis strategies comprising one (at N = 23), two (at N = 15, 30), or three interim analyses (at N = 11, 23, 34), respectively, which were defined post hoc.ResultsWhen performing interim analyses with one third and two thirds of patients, sufficient agreement could be concluded after the first interim analysis and the final analysis. Other partitions did not suggest early stopping after adjustment for multiple testing due to one influential outlier and our small sample size.ConclusionsGroup-sequential testing may enable early stopping of a trial, allowing for potential time and resource savings. The testing strategy must, though, be defined at the planning stage, and sample sizes must be reasonably large at interim analysis to ensure robustness against single outliers. Group-sequential testing may have a place in accuracy and agreement studies.Electronic supplementary materialThe online version of this article (10.1186/s13550-017-0328-6) contains supplementary material, which is available to authorized users.

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“…In a previous study from our department at Odense University Hospital, the use of PET/CT was compared with the standard breast cancer recurrence examination program of computed tomography (CT) scan and bone scintigraphy (NCT01552655) [13]. In this study, 100 women with previous breast cancer underwent CT, bone scintigraphy, and PET/CT, where the PET/CT set-up required two scans per day for the enrolled patients.…”

Section: Previous Clinical Study Without Ppimentioning

confidence: 99%

“…For the ongoing study, patient recruitment rates were available at ClinicalTrials.gov [14] and will be published elsewhere in a later phase of the study. For the previous study, data on expected patient recruitment were obtained from the study protocol available at the Department of Nuclear Medicine at Odense University Hospital, while data on observed patient recruitment were obtained from the final publication [13].…”

Section: Outcome Measures: Patient Recruitment and Retentionmentioning

confidence: 99%

Learning from patient involvement in a clinical study analyzing PET/CT in women with advanced breast cancer

et al. 2020

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Background: Despite increasing interest in patient involvement in health care research, researchers may be uncertain about the benefits of involving patients in the design and conduction of clinical studies. We aimed to evaluate the impact of patient involvement on patient recruitment and retention in a clinical study of PET/CT in women with advanced breast cancer. Further, we report our experience regarding the researchers' attitudes towards involving patients as partners in the research process. Methods: Two patient representatives from the Danish Breast Cancer Organization were invited as partners in the research team. These patient partners were asked to contribute in particular to participator information material and evaluation of ethical aspects of the study. The impact of patient involvement on patient recruitment was evaluated by comparing expected versus actual number of patients recruited, and then relating it to patient recruitment in a similar study at the same institution that did not involve patients as research partners. Results: Having patients as partners in the research team led to a major revision of the participator information material and improved patient recruitment. The expected number of patients was 260, but 380 were actually enrolled within the planned study period, thus 146% of the expected patient recruitment. In the previous study, only 100 of the expected 150 patients were enrolled during a 10-month extended study period, i.e. 67% of the expected number. Patient retention in the current study was high, with 86% of eligible patients attending follow-up scans. We observed initial resistance amongst researchers against inviting patients as team partners. This resistance gradually lessened during the study, and the most reluctant researchers at the beginning of the study later applauded the collaboration and the ideas generated by the patient representatives. Conclusion: Involving patients as partners in the research team resulted in major changes to the participator information material and contributed to higher than expected patient recruitment and retention. Furthermore, we observed a positive change of attitude amongst the researchers towards patient involvement in the research process.

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[¹⁸F]Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET)/Computed Tomography (CT) in Suspected Recurrent Breast Cancer: A Prospective Comparative Study of Dual-Time-Point FDG-PET/CT, Contrast-Enhanced CT, and Bone Scintigraphy

Cited by 78 publications

References 33 publications

Comparison of FDG-PET/CT and contrast-enhanced CT for monitoring therapy response in patients with metastatic breast cancer

Comparison of FDG-PET/CT and contrast-enhanced CT for monitoring therapy response in patients with metastatic breast cancer

Group-sequential analysis may allow for early trial termination: illustration by an intra-observer repeatability study

Learning from patient involvement in a clinical study analyzing PET/CT in women with advanced breast cancer

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[18F]Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET)/Computed Tomography (CT) in Suspected Recurrent Breast Cancer: A Prospective Comparative Study of Dual-Time-Point FDG-PET/CT, Contrast-Enhanced CT, and Bone Scintigraphy

Cited by 78 publications

References 33 publications

Comparison of FDG-PET/CT and contrast-enhanced CT for monitoring therapy response in patients with metastatic breast cancer

Comparison of FDG-PET/CT and contrast-enhanced CT for monitoring therapy response in patients with metastatic breast cancer

Group-sequential analysis may allow for early trial termination: illustration by an intra-observer repeatability study

Learning from patient involvement in a clinical study analyzing PET/CT in women with advanced breast cancer

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Resources

About

[¹⁸F]Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET)/Computed Tomography (CT) in Suspected Recurrent Breast Cancer: A Prospective Comparative Study of Dual-Time-Point FDG-PET/CT, Contrast-Enhanced CT, and Bone Scintigraphy