18F-FSPG PET/CT for Cancer Patients on Therapy
Mots clés
Abstrait
La description
OUTLINE:
Patients are evaluated with a PET/CT scan using the radiolabel 18F-FSPG [18F-(S)-4-(3-fluoropropyl)-L-glutamic acid] or 18F-FDG ([18F]-fluorodeoxyglucose), before and after therapeutic treatment.
PRIMARY OBJECTIVE:
Uptake of the radiolabel 18F-FSPG in patients with biopsy-proven cancer will be evaluated and compared to the uptake of 18F-FDG, before and after therapy (non-specified) in the same group of patients.
SECONDARY OBJECTIVES:
- Compare the agreement of the clinical assessment for cancer status between 18F-FSPG and 18F-FDG.
- Safety and tolerability of 18F-FSPG and 18F-FDG.
Rendez-vous
| Dernière vérification: | 11/30/2018 |
| Première soumission: | 10/31/2015 |
| Inscription estimée soumise: | 11/03/2015 |
| Première publication: | 11/05/2015 |
| Dernière mise à jour soumise: | 12/10/2018 |
| Dernière mise à jour publiée: | 01/02/2019 |
| Date des premiers résultats soumis: | 09/19/2018 |
| Date de la première soumission des résultats du CQ: | 12/10/2018 |
| Date des premiers résultats publiés: | 01/02/2019 |
| Date de début réelle de l'étude: | 06/30/2015 |
| Date d'achèvement primaire estimée: | 12/13/2016 |
| Date estimée d'achèvement de l'étude: | 12/13/2016 |
Condition ou maladie
Intervention / traitement
Drug: 18F-FSPG and 18F-FDG Intragroup Comparision
Drug: 18F-FSPG and 18F-FDG Intragroup Comparision
Phase
Groupes d'armes
| Bras | Intervention / traitement |
|---|---|
| Experimental: 18F-FSPG and 18F-FDG Intragroup Comparision Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. | Drug: 18F-FSPG and 18F-FDG Intragroup Comparision Administered intravenously (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: - Written informed consent - Able to complete a PET/CT scan without the use of sedation - Females: - Of childbearing potential must: - Not be nursing - Have a negative serum pregnancy test documented within 48 hours prior to administration of 18F FSPG PET/CT - Not of childbearing potential must be: - Physiologically postmenopausal (cessation of menses for more than 1 year) - Surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy) - Histologically confirmed cancer that is advanced; metastatic; or otherwise not suitable for surgical resection with curative intent - Scheduled to begin therapy - The time interval between 18F FSPG PET/CT and standard of care imaging (ie, 18F FDG PET/CT, diagnostic CT, or MRI) should be within 4 weeks (exceptions will be allowed for 6 weeks, if there are no other options) - Ideally, there should be no chemotherapy, radiotherapy, or immune/biologic therapy or biopsy between other imaging (PET/CTs, MRI, or diagnostic CTs) and 18F FSPG PET/CT scheduled or performed (exceptions by investigator discretion) - No clinically relevant deviations in renal function (serum creatinine > grade 2 Common Terminology Criteria for Adverse Events [CTCAE] version 4.0); maximal interval between confirmation of renal function and injection of 18F FSPG is 1 week Exclusion Criteria: - Scheduled for surgery and/or another invasive procedure (except biopsy) within the time period of 1 month prior to 18F FSPG administration - Known sensitivity to 18F FSPG or components of the preparation - Investigator precludes participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety |
Résultat
Mesures des résultats primaires
1. Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment [Baseline and up to 2 years]
Mesures des résultats secondaires
1. Number of Treatment-Related Adverse Events [Baseline to up to 2 years]
2. Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs [Baseline and up to 2 years]
