PET Imaging of Ovarian Carcinoma With 18F-FSPG
Mots clés
Abstrait
Rendez-vous
| Dernière vérification: | 05/31/2018 |
| Première soumission: | 07/25/2016 |
| Inscription estimée soumise: | 08/15/2016 |
| Première publication: | 08/18/2016 |
| Dernière mise à jour soumise: | 06/03/2018 |
| Dernière mise à jour publiée: | 06/05/2018 |
| Date de début réelle de l'étude: | 05/31/2018 |
| Date d'achèvement primaire estimée: | 07/31/2019 |
| Date estimée d'achèvement de l'étude: | 07/31/2020 |
Condition ou maladie
Intervention / traitement
Drug: Experimental
Procedure: Experimental
Other: Experimental
Phase
Groupes d'armes
| Bras | Intervention / traitement |
|---|---|
| Experimental: Experimental 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). | Drug: Experimental Given by IV |
Critère d'éligibilité
| Âges éligibles aux études | 18 Years À 18 Years |
| Sexes éligibles à l'étude | All |
| Accepte les bénévoles en santé | Oui |
| Critères | 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). |
Résultat
Mesures des résultats primaires
1. Lesion (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET standard uptake values [Up to 2 years]
2. Number of lesions detected by(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET [Up to 2 years]
3. Number of lesions detected by (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET imaging before and after neoadjuvant chemotherapy treatment [Up to 2 years]
Mesures des résultats secondaires
1. Immunohistochemistry evaluation of xC- and CD 44 of resected malignant ovarian cancer with a measurement of strength of staining from 0-3. [Up to 2 years]
2. Proportion of patients whose surgical resection by novel imaging classification changed following validation by histological confirmation [Up to 2 years]
3. Proportion of patients whose response to chemotherapy changed by Response Evaluation Criteria in Solid Tumors criteria [Up to 2 years]
4. Conditional predictive models of imaging performance and agreement [Up to 2 years]
