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Utility of Preoperative FDG-PET/CT and Ferumoxtran-10 MRI Scanning 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 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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Cervical Adenocarcinoma, Cervical Adenosquamous Cell Carcinoma, Cervical Small Cell Carcinoma, Cervical Squamous Cell Carcinoma, Endometrial Clear Cell Carcinoma, Endometrial Papillary Serous Carcinoma, Stage I Endometrial Carcinoma, Stage IB Cervical Cancer, Stage II Endometrial Carcinoma, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer, Stage III Endometrial Carcinoma, Stage IVA Cervical Cancer

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Trial Information

Utility of Preoperative FDG-PET/CT and Ferumoxtran-10 MRI Scanning 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 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


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.


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

- 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 ACRIN-affiliated institution that is accredited
by 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Diagnostic sensitivity and specificity of preoperative fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scanning

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Mostafa Atri

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00600

NCT ID:

NCT00416455

Start Date:

September 2007

Completion Date:

Related Keywords:

  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Cell Carcinoma
  • Cervical Small Cell Carcinoma
  • Cervical Squamous Cell Carcinoma
  • Endometrial Clear Cell Carcinoma
  • Endometrial Papillary Serous Carcinoma
  • Stage I Endometrial Carcinoma
  • Stage IB Cervical Cancer
  • Stage II Endometrial Carcinoma
  • Stage IIA Cervical Cancer
  • Stage IIB Cervical Cancer
  • Stage III Cervical Cancer
  • Stage III Endometrial Carcinoma
  • Stage IVA Cervical Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Uterine Cervical Neoplasms
  • Neoplasm Metastasis
  • Small Cell Lung Carcinoma
  • Carcinoma, Small Cell
  • Carcinoma, Adenosquamous
  • Adenocarcinoma, Clear Cell
  • Adenomyoepithelioma
  • Cystadenocarcinoma, Serous
  • Adenoma
  • Endometrial Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Sarasota Memorial HospitalSarasota, Florida  34239
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Weill Medical College of Cornell UniversityNew York, New York  10021
Mount Sinai Medical CenterNew York, New York  10029
Vanderbilt UniversityNashville, Tennessee  37232-6305
Case Western Reserve UniversityCleveland, Ohio  44106
Wayne State UniversityDetroit, Michigan  48202
University of CincinnatiCincinnati, Ohio  45267-0502
The Hospital of Central ConnecticutNew Britain, Connecticut  06050
Women and Infants HospitalProvidence, Rhode Island  02905
UMDNJ - New Jersey Medical SchoolNewark, New Jersey  07103
Olive View-University of California Los Angeles Medical CenterSylmar, California  91342
Montefiore Medical Center-Weiler DivisionBronx, New York  10461
Georgia Health Sciences UniversityAugusta, Georgia  30912
Jonsson Comprehensive Cancer CenterLos Angeles, California  90095