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

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Stage IVA Cervical Cancer

Stage I Endometrial Carcinoma

Cervical Adenocarcinoma

Stage IB Cervical Cancer

Endometrial Clear Cell Carcinoma

Stage II Endometrial Carcinoma

Cervical Adenosquamous Cell Carcinoma

Stage III Cervical Cancer

Stage IIB Cervical Cancer

Stage IIA Cervical Cancer

Cervical Squamous Cell Carcinoma

Endometrial Papillary Serous Carcinoma

Stage III Endometrial Carcinoma

Cervical Small Cell Carcinoma

Treatments

Procedure: positron emission tomography

Procedure: diagnostic lymphadenectomy

Procedure: lymph node biopsy

Procedure: computed tomography

Procedure: magnetic resonance imaging

Drug: ferumoxtran-10

Radiation: fludeoxyglucose F 18

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00416455

NCI-2009-00600 (Registry Identifier)

U10CA027469 (U.S. NIH Grant/Contract)

GOG-0233-ACRIN 6671 (Other Identifier)

U10CA180868 (U.S. NIH Grant/Contract)

GOG-0233 (Other Identifier)

CDR0000521453

ACRIN 6671

GOG-0233/ACRIN 6671

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. Determine the diagnostic sensitivity and specificity of preoperative fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to abdominal (common iliac, para-aortic, and paracaval) lymph nodes in patients with locoregionally advanced cervical carcinoma.

II. Determine the diagnostic sensitivity and specificity of preoperative FDG-PET/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to retroperitoneal abdominal lymph nodes in patients with high-risk endometrial cancer.

SECONDARY OBJECTIVES:

I. Determine the diagnostic sensitivity and specificity of preoperative FDG-PET/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to pelvic lymph nodes and pelvic and abdominal lymph nodes combined in patients with locoregionally advanced cervical carcinoma or high-risk endometrial cancer.

II. Compare the additive diagnostic value of CT fusion (PET/CT scan) vs PET scanning alone in identifying metastases to pelvic, abdominal, and combined (all regions) lymph nodes in these patients.

III. Compare the diagnostic sensitivity and specificity of PET/CT scanning vs ferumoxtran-10 MRI scanning in identifying metastases to pelvic, abdominal, and combined lymph nodes in these patients.

IV. Compare the diagnostic sensitivity and specificity of ferumoxtran-10 MRI vs MRI alone, in terms of size criteria in the abdomen and pelvis, in these patients.

V. Determine the percentage of patients with locoregionally advanced cervical cancer or high-risk endometrial cancer who have biopsy-proven disease outside the abdominal or pelvic lymph nodes detected by PET/CT scanning.

VI. Determine the accuracy of MRI in determining the depth of myometrial invasion and involvement of cervix in patients with high-risk endometrial cancer.

VII. Determine the complications associated with extraperitoneal or laparoscopic abdominal and pelvic lymphadenectomy in patients with locoregionally advanced cervical cancer.

VIII. Determine the cause(s) of delay in the initiation of radiotherapy or interruption in radiotherapy in patients with locoregionally advanced cervical cancer.

IX. Collect data on the adverse effects of ferumoxtran-10 in patients with locoregionally advanced cervical carcinoma or high-risk endometrial cancer.

X. Compare the size of lymph nodes in pre- and post-ferumoxtran-10 MRI's in a subset of forty patients.

OUTLINE: This is a multicenter study.

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.

After completion of study therapy, patients are followed at 6 weeks, 6 months, every 3 months for 2 years, and then every 6 months for 3 years.

Enrollment

384 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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 agents