Utility of Preoperative PET-CT & USPIO MRI Prior to Primary Chemoradiation Therapy to Detect Retroperitoneal Lymph Node Metastasis in Patients With Locoregionally Advanced (IB2, IIA =4 CM, IIB-IVA) Carcinoma of the Cervix

Protocol Documents 

Protocol-GOG-0233/ACRIN 6671 Amendment 5, 11.25.08 [PDF]

SOC-GOG-0233/ACRIN 6671 Amendment 5, 11.25.08 [PDF]

Informed Consent-GOG 0233/ACRIN 6671 [DOC]

Spanish Language Informed Consent-GOG 0233/ACRIN 6671-Amendment 4 [DOC]

Spanish Language Informed Consent Certificate of Accuracy-Amendment 4 [PDF]

Principal Investigator: Mostafa Atri, MD, ACRIN Principal Investigator
                                      Michael Gold, MD, GOG Study Chair
Status: Open

Primary Objectives: 

• To evaluate the diagnostic sensitivity and specificity of preoperative FDG-PET/CT imaging in identifying metastases to abdominal (common iliac, para-aortic, and para-caval) lymph nodes in patients with locoregionally advanced cervical carcinoma.
• To evaluate the diagnostic sensitivity and specificity of preoperative ferumoxtran-10 (Combidex) MRI scanning in identifying metastases to abdominal (common iliac, para-aortic, and para-caval) lymph nodes in patients with locoregionally advanced cervical carcinoma.

Participants:  Participating women must have primary, previously untreated, histologically confirmed, locoregionally advanced (IB2, IIA ≥4cm, IIB-IVA) invasive carcinoma of the cervix (any cell type) and must be appropriate surgical candidates to undergo extra-peritoneal or laparoscopic lymph node sampling.