Clinical trial · Interventional
PET Imaging of Ovarian Carcinoma With 18F-FSPG
NCT02872519CI-TRIAL-00033199withdrawnEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IIIA Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Primary Peritoneal Cancer | — | UNRESOLVED | — |
| Stage IIIB Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Primary Peritoneal Cancer | — | UNRESOLVED | — |
| Stage IIIC Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Primary Peritoneal Cancer |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
| (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- 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).
- interventionNames
- Drug: (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG)
- Procedure: Positron Emission Tomography
- Other: Laboratory Biomarker Analysis
Primary outcomes (3)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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).References
Publications (0)
Data not yet available
No reference posted for this study.