Pilot Study to Assess the Potential Clinical Utility of 18F Fluciclovine PET for Cervical and Endometrial Cancer.
Pilot Study to Assess the Potential Clinical Utility of 18F Fluciclovine PET for Cervical and Endometrial Cancer.
18F Fluciclovine is a recently FDA- approved radiopharmaceutical for prostate cancer
 biochemical recurrence, which is only minimally eliminated by the kidneys and therefore the
 image interpretation is not affected by nonspecific urine activity in the ureters and
 bladder, which is advantageous for pelvic imaging. Recent literature suggests that
 Fluciclovine PET has diagnostic potential for a variety of solid tumors, thus, allowing new
 opportunities for noninvasive probing of glutamine metabolism and clinical use in patient
 management. Current literature indicates that amino acid transporters including that of
 glutamine are upregulated in endometrial and cervical cancer so that Fluciclovine PET may
 have clinical potentials. The hypothesis is that Fluciclovine PET provides better imaging
 properties and greater diagnostic confidence and accuracy than FDG PET does in pelvic
 malignancies.

 Given the lack of current clinical data, a pilot study providing a direct comparison of
 Fluciclovine PET with FDG PET is warranted. The investigators seek to conduct a pilot study
 with 10 subjects to evaluate the clinical utility of Fluciclovine PET for staging of cervical
 cancer and endometrial cancer. This research will compare the diagnostic performance of the
 research Fluciclovine PET/MRI with the standard-of-care FDG PET/CT as an exploratory
 endpoint.
Background:

 Endometrial cancer arises from the inner lining of the uterus and is one of the most common
 malignancies in women, representing 3.6% of all new cancer cases in the US. It is estimated
 that there are more than 60,000 new cases of endometrial cancer and more than 10,000 people
 will die of this malignancy in 2016. It is most frequently diagnosed among women aged 55-64.
 Cervical cancer starts in the cervix, the lower part of the uterus. Its prevalence is lower
 compared with endometrial cancer thank to effective screening and early disease detection
 with the Pap smear. In 2016, it is estimated that there will be more than 12,000 new cases of
 cervical cancer and more than 4,000 patients will die of this disease in the US.

 Positron Emission Tomography (PET) combined with Computed Tomography (CT) is an essential
 part of the workup for many malignancies. F-18 FDG PET/CT is currently the standard-of-care
 (SOC) PET/CT modality for staging and restaging of pelvic malignancies in women. But there
 are certain diagnostic limitations related to F-18 FDG because it is mainly eliminated by the
 kidneys and often interferes with the detection of cancer lesions, particularly in the
 abdominal and pelvic regions. On the other hand, the recently FDA approved F-18 Fluciclovine
 is only minimally eliminated by the kidneys and therefore the image interpretation is not
 affected by nonspecific urine activity in the ureters and bladder, which is advantageous for
 pelvic imaging. Recent literature suggests that Fluciclovine PET has diagnostic potential for
 a variety of solid tumors, thus, allowing new opportunities for noninvasive probing of
 glutamine metabolism and clinical use in patient management.

 Current literature indicates that amino acid transporters including that of glutamine are
 upregulated in endometrial and cervical cancer so that Fluciclovine PET may have clinical
 potentials. The hypothesis is that Fluciclovine PET provides better imaging properties and
 greater diagnostic confidence and accuracy than FDG PET does in pelvic malignancies.

 Given the lack of current clinical data, a pilot study providing a direct comparison of
 Fluciclovine PET with FDG PET is warranted.

 Objective:

 The investigators seek to conduct a pilot study to evaluate the clinical utility of
 Fluciclovine PET for staging of cervical cancer and endometrial cancer. This research will
 focus on pelvic imaging comparing the diagnostic performance of the research Fluciclovine
 PET/MRI with SOC FDG PET/CT as an exploratory endpoint. Dynamic PET imaging on a hybrid
 PET/MR scanner will provide valuable pharmacokinetic information that can be used to identify
 the optimal time window for the detection and characterization of the primary tumor and
 pelvic nodal disease. Additional abdominal imaging will allow for further correlation with
 FDG PET/CT in terms of nodal disease and distant metastasis detection. As previously
 demonstrated in prostate cancer, the Fluciclovine uptake can be heterogeneous which may have
 diagnostic and prognostic implications. Therefore, this pilot study will provide valuable
 information on potential Fluciclovine heterogeneity in cervical and uterine cancer. Textural
 heterogeneity of the primary will be compared between Fluciclovine and FDG PET. The initial
 experience gained with this pilot study will provide valuable insights into the
 pharmacokinetics and textural heterogeneity of Fluciclovine PET in cervical and uterine
 cancers, and presents the first data on the potential strengths and weaknesses of
 Fluciclovine PET/MR compared with FDG PET/CT.

 1. The investigators hypothesize that Fluciclovine PET is non-inferior to FDG PET regarding
 detection of the primary tumor.

 2. It is hypothesized that nodal disease staging is more accurate with Fluciclovine than
 with FDG PET because of the low level of nonspecific urinary bladder and ureter
 activity.

 3. It is hypothesized that the dynamic uptake pattern of the primary lesion correlates with
 the tumor grading on histopathology.

 4. It is hypothesized that textural heterogeneity is different between Fluciclovine and FDG
 PET.

 Specific Aims:

 -  To study the pharmacokinetics of Fluciclovine PET in women with cervical and uterine
 cancers

 -  To characterize physiologic uptake pattern of the uterus and ovaries when these are not
 affected by tumor.

 -  To identify the optimal time window for the quantitative analysis of Fluciclovine
 primary and pelvic nodal disease

 -  To correlate the time-activity curve pattern of the primary lesion with histopathologic
 tumor grading

 -  To compare diagnostic performance of Fluciclovine PET and FDG PET

 -  To compare textural heterogeneity of the primary between Fluciclovine PET and FDG PET

 Significance:

 The initial experience gained with this pilot study will provide valuable insights into the
 pharmacokinetics, lesion detectability and textural heterogeneity of Fluciclovine PET in
 cervical cancer and uterine cancer. The study provides preliminary data on the potential
 strengths and weaknesses of Fluciclovine PET/MR compared with the SOC FDG PET/CT.

 Fluciclovine PET may provide a significant improvement in the TNM staging compared with FDG
 PET as it is not affected by nonspecific urine activity in the ureters and bladder, which is
 a common diagnostic problem for FDG PET. By combining the excellent soft-tissue contrast of
 MRI with Fluciclovine PET, the hybrid PET/MR scanning could be a convenient and effective
 one-stop imaging procedure providing both pelvic TNM staging and whole-body M staging.
 Moreover, valuable prognostic information may be derived from Fluciclovine PET
 pharmacokinetics and heterogeneity assessment as well as multi-parametric PET/MR evaluation.
Inclusion Criteria:

 -  Female

 -  18 years and older

 -  Biopsy-proved cervical cancer or endometrial cancer within three months of study
 enrollment

 -  Standard-of-care (SOC) FDG PET/CT exam performed within 30 days of study enrollment

 Exclusion Criteria:

 -  Female < 18 years old

 -  No history of cervical cancer or endometrial cancer

 -  Primary biopsy > 3 months of study enrollment

 -  Systemic therapy or radiation therapy initiated

 -  SOC FDG PET/CT exam performed > 30 days of study enrollment

 -  Therapeutic procedures (chemotherapy, radiation therapy) have been initiated

 -  Pregnancy or lactation

 -  Claustrophobia or inability to tolerate the imaging procedure on the PET/MR scanner

 -  Individual is not willing to give informed consent