Pilot Study to Assess the Potential Clinical Utility of 18F Fluciclovine PET for Cervical and Endometrial Cancer.
| Status: | Recruiting |
|---|---|
| Conditions: | Cervical Cancer, Cervical Cancer, Cervical Cancer, Cancer, Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/16/2018 |
| Start Date: | December 11, 2018 |
| End Date: | December 30, 2019 |
| Contact: | Suzanne Burdin |
| Email: | burdins@upmc.edu |
| Phone: | 412-647-7385 |
Pilot Study to Assess the Potential Clinical Utility of 18F Fluciclovine PET for Cervical and Endometrial Cancer Compared With 18F FDG PET
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.
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.
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
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