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PET Imaging of Ovarian Carcinoma With 18F-FSPG

Primary Purpose

Stage IIIA Fallopian Tube Cancer, Stage IIIA Ovarian Cancer, Stage IIIA Primary Peritoneal Cancer

Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG)
Positron Emission Tomography
Laboratory Biomarker Analysis
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stage IIIA Fallopian Tube Cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have a presumed diagnosis of advanced stage epithelial ovarian, fallopian tube, or peritoneal.

    • Pelvic mass and/or omental caking with Ca-125:CEA ratio 25:1.

      • Adequate performance status, ECOG 0, 1, 2.

  • Adequate organ function:

    • PCV > 30 (with or without transfusion)
    • WBC: 3000 - 10,000 The lower level of normal for total WBCs is 4,000, but the NCI considers levels of 3,000- 4,000 as mild suppression for drug trials, specifically not requiring treatment.
    • Platelet count > 150, 000 and < 1,000,000
    • Cr < 1.5
    • LFTS < 1.5 x ULN
  • Have undergone or have agreed to undergo standard of care CT of the chest, abdomen, and pelvis. 18F-FSPG PET imaging will be performed as investigational studies.
  • No prior treatment for ovarian cancer
  • have undergone or agree to undergo standard of care imaging for ovarian cancer with CT chest, abdomen, and pelvis.

Exclusion Criteria:

  • Have non-invasive or non-epithelial ovarian cancer on pathological confirmation.
  • Pregnant and breastfeeding
  • Poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL).
  • Other poorly controlled medical conditions that in the opinion of the surgeon, make them not a candidate for primary cytoreductive surgery.

  • CT of chest, abdomen, pelvis demonstrates:

    • Any disease in the thoracic cavity > 1 cm.
    • Any suprarenal lymphadenopathy > 1 cm.
    • Liver metastases > 1 cm.
    • Disease in the porta hepatis or gallbladder fossa > 1 cm.
    • Pleural effusion > 50% volume of the chest cavity on chest x-ray.

    • Omental extension to the stomach, spleen, or lesser sac.

      • Extension to the pelvic sidewall (this criteria may also be assessed on physical examination.
      • involvement of the root of the mesentery.
  • Decline procedures that might be necessary for optimal primary cytoreduction (i.e. colostomy or splenectomy).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Experimental

    Arm Description

    Patients receive (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET scans. Patients undergo PET imaging scans during 0-45 minutes, 60-75 minutes, and 105-120 minutes after injection and within 4 weeks prior to surgery (Cohort A) or within 4 weeks of SOC imaging at diagnosis and prior to subsequent treatment (Cohort B).

    Outcomes

    Primary Outcome Measures

    Lesion (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET standard uptake values
    Number of lesions detected by(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET
    Number of lesions detected by (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET imaging before and after neoadjuvant chemotherapy treatment

    Secondary Outcome Measures

    Immunohistochemistry evaluation of xC- and CD 44 of resected malignant ovarian cancer with a measurement of strength of staining from 0-3.
    All imaging data (SUV) will be correlated to definitive, ex vivo diagnostic pathology and immunoreactivity (xC-, CD44), which will be carried out for every patient with resected tissue. and, when IHC scoring will be in terms of strength of immunostaining (scored on an ordinal scale of 0 3). This treatment of lesion-based sensitivity and specificity has not been previously described in the ovarian cancer literature.
    Proportion of patients whose surgical resection by novel imaging classification changed following validation by histological confirmation
    Proportion of patients whose response to chemotherapy changed by Response Evaluation Criteria in Solid Tumors criteria
    Conditional predictive models of imaging performance and agreement
    We will test that lesion 18F-FSPG PET SUV's are significantly greater than background (normal liver tissue) by tissue assessment of number of lesions noted in each arm and after treatment.

    Full Information

    First Posted
    July 26, 2016
    Last Updated
    June 4, 2018
    Sponsor
    Vanderbilt-Ingram Cancer Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02872519
    Brief Title
    PET Imaging of Ovarian Carcinoma With 18F-FSPG
    Official Title
    PET Imaging of Ovarian Carcinoma With 18F-FSPG
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No funding
    Study Start Date
    June 2018 (Anticipated)
    Primary Completion Date
    August 2019 (Anticipated)
    Study Completion Date
    August 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vanderbilt-Ingram Cancer Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This clinical trial studies positron emission tomography (PET) imaging utilizing 18F-FSPG [(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid], a glutamic acid derivative, to image patients with ovarian cancer before undergoing surgery or transplant. Diagnostic procedures, such as 18F-FSPG PET, may help find and diagnose ovarian cancer and find out how far the disease has spread.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stage IIIA Fallopian Tube Cancer, Stage IIIA Ovarian Cancer, Stage IIIA Primary Peritoneal Cancer, Stage IIIB Fallopian Tube Cancer, Stage IIIB Ovarian Cancer, Stage IIIB Primary Peritoneal Cancer, Stage IIIC Fallopian Tube Cancer, Stage IIIC Ovarian Cancer, Stage IIIC Primary Peritoneal Cancer, Stage IV Fallopian Tube Cancer, Stage IV Ovarian Cancer, Stage IV Primary Peritoneal Cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    Patients receive (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET scans. Patients undergo PET imaging scans during 0-45 minutes, 60-75 minutes, and 105-120 minutes after injection and within 4 weeks prior to surgery (Cohort A) or within 4 weeks of SOC imaging at diagnosis and prior to subsequent treatment (Cohort B).
    Intervention Type
    Drug
    Intervention Name(s)
    (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG)
    Intervention Description
    Given by IV
    Intervention Type
    Procedure
    Intervention Name(s)
    Positron Emission Tomography
    Intervention Description
    Undergo scan
    Intervention Type
    Other
    Intervention Name(s)
    Laboratory Biomarker Analysis
    Intervention Description
    Laboratory Biomarker Analysis
    Primary Outcome Measure Information:
    Title
    Lesion (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET standard uptake values
    Time Frame
    Up to 2 years
    Title
    Number of lesions detected by(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET
    Time Frame
    Up to 2 years
    Title
    Number of lesions detected by (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET imaging before and after neoadjuvant chemotherapy treatment
    Time Frame
    Up to 2 years
    Secondary Outcome Measure Information:
    Title
    Immunohistochemistry evaluation of xC- and CD 44 of resected malignant ovarian cancer with a measurement of strength of staining from 0-3.
    Description
    All imaging data (SUV) will be correlated to definitive, ex vivo diagnostic pathology and immunoreactivity (xC-, CD44), which will be carried out for every patient with resected tissue. and, when IHC scoring will be in terms of strength of immunostaining (scored on an ordinal scale of 0 3). This treatment of lesion-based sensitivity and specificity has not been previously described in the ovarian cancer literature.
    Time Frame
    Up to 2 years
    Title
    Proportion of patients whose surgical resection by novel imaging classification changed following validation by histological confirmation
    Time Frame
    Up to 2 years
    Title
    Proportion of patients whose response to chemotherapy changed by Response Evaluation Criteria in Solid Tumors criteria
    Time Frame
    Up to 2 years
    Title
    Conditional predictive models of imaging performance and agreement
    Description
    We will test that lesion 18F-FSPG PET SUV's are significantly greater than background (normal liver tissue) by tissue assessment of number of lesions noted in each arm and after treatment.
    Time Frame
    Up to 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have a presumed diagnosis of advanced stage epithelial ovarian, fallopian tube, or peritoneal. Pelvic mass and/or omental caking with Ca-125:CEA ratio 25:1. Adequate performance status, ECOG 0, 1, 2. Adequate organ function: PCV > 30 (with or without transfusion) WBC: 3000 - 10,000 The lower level of normal for total WBCs is 4,000, but the NCI considers levels of 3,000- 4,000 as mild suppression for drug trials, specifically not requiring treatment. Platelet count > 150, 000 and < 1,000,000 Cr < 1.5 LFTS < 1.5 x ULN Have undergone or have agreed to undergo standard of care CT of the chest, abdomen, and pelvis. 18F-FSPG PET imaging will be performed as investigational studies. No prior treatment for ovarian cancer have undergone or agree to undergo standard of care imaging for ovarian cancer with CT chest, abdomen, and pelvis. Exclusion Criteria: Have non-invasive or non-epithelial ovarian cancer on pathological confirmation. Pregnant and breastfeeding Poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL). Other poorly controlled medical conditions that in the opinion of the surgeon, make them not a candidate for primary cytoreductive surgery. CT of chest, abdomen, pelvis demonstrates: Any disease in the thoracic cavity > 1 cm. Any suprarenal lymphadenopathy > 1 cm. Liver metastases > 1 cm. Disease in the porta hepatis or gallbladder fossa > 1 cm. Pleural effusion > 50% volume of the chest cavity on chest x-ray. Omental extension to the stomach, spleen, or lesser sac. Extension to the pelvic sidewall (this criteria may also be assessed on physical examination. involvement of the root of the mesentery. Decline procedures that might be necessary for optimal primary cytoreduction (i.e. colostomy or splenectomy).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marta Crispens, MD
    Organizational Affiliation
    Vanderbilt University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    PET Imaging of Ovarian Carcinoma With 18F-FSPG

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