Clinical trial · Interventional
Groin Sentinel Node Biopsy and 18FDG-PET/CT in cN0 Vulvar Cancer Patients Candidate to Standard Lymphadenectomy
Study on the Prediction of Groin Lymphonodal Status Through 18FDG-PET/CT Combined With Sentinel Lymph Node Biopsy in Bulky a/o Multifocal a/o Pretreated Vulvar Cancer, N0 at Conventional Imaging (GRO-SNaPET Study)
NCT02969278CI-TRIAL-00024851GroSNaPETunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study aim is to verify the accuracy of SNB combined with 18F-FDG PET/CT in cN0 invasive vulvar cancer (IVC) patients currently not candidate to SNB according to standard guidelines.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18FDG-PET/TC | Procedure | — | UNRESOLVED |
| Sentinel node biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vulvar cancer patients cN0 unfit for sentinel node biopsy
- description
- All invasive vulvar cancer patients with cN0 status: * T \> 4 cm; * multicentric tumors (mono or bilateral); * primary lesion completely excised during prior diagnostic surgery * patients candidate to bilateral lymphadenectomy because of unilateral groin lymph node involvement, contralateral cN0 * previous radiotherapy a/o chemotherapy (sequential or concurrent). These patients are submitted to 18FDG PET/TC and sentinel node biopsy associated with standard preoperative imaging and radical groin lymphadenectomy
- interventionNames
- Procedure: 18FDG-PET/TC
- Procedure: Sentinel node biopsy
Primary outcomes (1)
- measure
- Accuracy and Negative Predictive Value of sentinel node biopsy in cN0 vulvar cancer patients that do not fit for the current indications
- timeFrame
- within the first 30 days after surgery
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age\> 18 years * ECOG ≤ 2 * Adequate respiratory, hepatic, cardiac, bone marrow and renal function (creatinine clearance\> 60 mL/min according to the Cockroft formula) * Patient psychologically able to follow the study procedures * Signature of informed consent In addition, both major criteria and at least one of the minor criteria must be present: MAJOR CRITERIA * Vulvar carcinoma (stromal infiltration \> 1 mm); Histotypes different from squamous are included * Negative lymphnodes at preoperative imaging MINOR CRITERIA * Vulvar lesion greater than 4 cm * Multifocal or bilateral lesions * Previous complete excisional biopsy of the vulvar lesion, with absent residual disease * Previous neoadjuvant treatment (radiotherapy a/o sequential/concomitant chemotherapy) * Previous treatment with radiotherapy a/o chemotherapy (sequential a/o concomitant) for previous vulvar cancer a/o other diseases * Previous vulvar or inguinal surgery * Infiltrating vulvar carcinoma with monolateral groin lymphnode involvement (N1) and contralateral N0 Exclusion Criteria: * Allergy to egg proteins and albumin * Pregnancy and breastfeeding * Patients with impaired respiratory, hepatic, cardiac, bone marrow and renal function (creatinine clearance\> 60 mL / min according to the Cockroft formula) * Patients with major depressive disorder
References
Publications (0)
Data not yet available
No reference posted for this study.