Clinical trial NCT02872519: PET Imaging of Ovarian Carcinoma With 18F-FSPG
Official title: PET Imaging of Ovarian Carcinoma With 18F-FSPG
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: 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
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-08-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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).

Primary outcomes:
measure: Lesion (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET standard uptake values
timeFrame: Up to 2 years
measure: Number of lesions detected by(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET
timeFrame: Up to 2 years
measure: Number of lesions detected by (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET imaging before and after neoadjuvant chemotherapy treatment
timeFrame: Up to 2 years
Secondary outcomes:
measure: Immunohistochemistry evaluation of xC- and CD 44 of resected malignant ovarian cancer with a measurement of strength of staining from 0-3.
timeFrame: Up to 2 years
measure: Proportion of patients whose surgical resection by novel imaging classification changed following validation by histological confirmation
timeFrame: Up to 2 years
measure: Proportion of patients whose response to chemotherapy changed by Response Evaluation Criteria in Solid Tumors criteria
timeFrame: Up to 2 years
measure: Conditional predictive models of imaging performance and agreement
timeFrame: Up to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University Medical Center
name: Marta Crispens, MD
role: PRINCIPAL_INVESTIGATOR
References: