Clinical trial · Interventional
Fludeoxyglucose (FDG) F 18 PET Scan, CT Scan, and Ferumoxtran-10 MRI Scan Before Chemotherapy and Radiation Therapy in Finding Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer or High-Risk Endometrial Cancer
Utility of Preoperative FDG-PET/CT Scanning Prior to Primary Chemoradiation Therapy to Detect Retroperitoneal Lymph Node Metastasis in Patients With Locoregionally Advanced Carcinoma of the Cervix (IB2, IIA ≥ 4 CM, IIB-IVA) or Endometrium (Grade 3 Endometrioid Endometrial Carcinoma; Serous Papillary Carcinoma, Clear Cell Carcinoma, or Carcinosarcoma (Any Grade); and Grade 1 OR 2 Endometrioid Endometrial Carcinoma With Cervical Stromal Involvement Overt in Clinical Examination or Confirmed by Endocervical Curettage
- 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)
This phase I/II trial is studying how well fludeoxyglucose F 18 PET scan, CT scan, and ferumoxtran-10 MRI scan finds lymph node metastasis before undergoing chemotherapy and radiation therapy in patients with locally advanced cervical cancer or high-risk endometrial cancer. Diagnostic procedures, such as a fludeoxyglucose F 18 positron emission tomography (PET) scan, computed tomography (CT) scan, and ferumoxtran-10 magnetic resonance imaging (MRI) scan, may help find lymph node metastasis in patients with cervical cancer or endometrial cancer.
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Adenocarcinoma | Cervical Adenocarcinoma | CURATED_BROADER | 0.80 |
| Cervical Adenosquamous Cell Carcinoma | Cervical Adenosquamous Carcinoma | ALIAS | 0.90 |
| Cervical Small Cell Carcinoma | Cervical Small Cell Neuroendocrine Carcinoma | ALIAS | 0.90 |
| Cervical Squamous Cell Carcinoma | Cervical Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
| Endometrial Clear Cell Carcinoma | — | UNRESOLVED | — |
| Endometrial Papillary Serous Carcinoma | — | UNRESOLVED | — |
| Stage IB Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| computed tomography | Procedure | — | UNRESOLVED |
| diagnostic lymphadenectomy | Procedure | — | UNRESOLVED |
| ferumoxtran-10 | Drug | — | UNRESOLVED |
| fludeoxyglucose F 18 | Radiation | — | UNRESOLVED |
| lymph node biopsy | Procedure | — | UNRESOLVED |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| positron emission tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (diagnostic scans, surgery, chemotherapy, radiation)
- description
- Patients receive fludeoxyglucose F 18 (FDG) IV followed 60 minutes later by positron emission tomography (PET)/CT scanning on day 1. Patients also receive ferumoxtran-10 IV over 30-45 minutes on day 1 (or 24-36 hours before MRI) and undergo MRI on day 2. Patients undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Patients diagnosed with metastatic disease prior to lymph node biopsy proceed directly to primary treatment. Patients with cervical cancer undergo chemoradiotherapy within 4 weeks of PET/CT scan.
- interventionNames
- Radiation: fludeoxyglucose F 18
- Procedure: positron emission tomography
- Procedure: computed tomography
- Drug: ferumoxtran-10
- Procedure: magnetic resonance imaging
- Procedure: diagnostic lymphadenectomy
- Procedure: lymph node biopsy
Primary outcomes (2)
- measure
- The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of 1 of the following:
* Invasive carcinoma of the cervix meeting all of the following criteria:
* Previously untreated, primary disease
* Locoregionally advanced (stage IB2, IIA \[\>= 4 cm\], or IIB-IVA) disease
* Any cell type allowed
* High-risk endometrial carcinoma meeting 1 of the following criteria:
* Grade 3 endometrioid or non-endometrioid endometrial carcinoma (clear cell or serous papillary) or carcinosarcoma diagnosed from an endometrial biopsy or dilation and curettage or
* Grade 1 or 2 endometrioid endometrial carcinoma with cervical stromal involvement overt on clinical examination or confirmed by endocervical curettage
* Under consideration for chemoradiotherapy (patients with cervical cancer)
* Undergone appropriate surgery for cervical or endometrial carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage
* Appropriate surgical candidate to undergo extraperitoneal or laparoscopic lymph node sampling OR hysterectomy and lymph node sampling
* No surgery for patients with advanced lymphadenopathy
* No recurrent invasive carcinoma of the uterus or uterine cervix regardless of previous treatment
* No known metastases to the lungs or scalene lymph nodes
* No metastases to other organs outside of the pelvis or abdominal lymph nodes at the time of the original clinical diagnosis
* Patients with endometrial cancer with known intraperitoneal disease are eligible provided they undergo pelvic and para-aortic lymphadenectomy per protocol
* Participants must be enrolled at an American College of Radiology Imaging Network (ACRIN)-affiliated institution that is accredited by Gynecologic Oncology Group (GOG)
* GOG performance status 0-2
* Creatinine within normal institutional limits OR, in participants with creatinine levels above institutional normal, glomerular filtration rate (GFR) must be \> 60 mL/min; there is no lower limit of normal for serum creatinine for this protocol
* Ferritin levels =\< 600 ng/mL OR saturation of transferrin level =\< 50%
* Patients with high levels of ferritin or transferrin are eligible if documented hematology rules out iron overload
* Not pregnant or nursing
* Negative pregnancy test
* No patients weighing greater than that allowable by the PET/CT scanner
* No renal abnormalities, such as a pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of the lymphadenectomy
* No history of anaphylactic or life-threatening allergic reactions to any contrast media
* No other invasive malignancies within the past 5 years with the exception of nonmelanoma skin cancer
* No contraindication to MRI (e.g., severe claustrophobia, pacemaker, aneurysm clips, defibrillators, or other institutional contraindication to MRI)
* No history of allergic reactions attributed to compounds of similar chemical or biological composition to ferumoxtran-10 (e.g., iron preparations, parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations)
* No immunodeficiencies that would predispose patient to specific or nonspecific mediator release
* No history of cirrhosis
* No poorly controlled, insulin-dependent diabetes (i.e., fasting blood glucose level \> 200 mg/dL)
* No prior pelvic or abdominal lymphadenectomy
* No prior pelvic radiotherapy
* No prior anticancer therapy that would contraindicate study participation
* No ferumoxides within the past 2 weeks
* No investigational agents within the past 30 days
* No other concurrent investigational agentsReferences
Publications (0)
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