Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer



Status:Recruiting
Conditions:Cervical Cancer, Cervical Cancer, Cervical Cancer, Cancer, Cancer, Women's Studies, Endometrial Cancer
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:November 2014
End Date:November 2020
Contact:Jennifer Mueller, MD
Email:muellerj@mskcc.org
Phone:212-639-8229

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The purpose of this study is to see if a radioactive substance called 18F-Fluorodeoxyglucose
(18F- FDG), injected into the cervix during a PET/CT scan done before surgery can show us
more clearly which lymph nodes in the pelvis (the area near your uterus and cervix) contain
cancer.


Inclusion Criteria:

- The study population will include women with stage IB1 cervical cancer (any histologic
subtype) deemed eligible for surgery, and women with a clinical stage I high-grade
endometrial cancer planning to undergo surgical staging. High grade is defined by the
following:

- Uterine serous carcinoma

- Clear cell endometrial carcinoma

- Grade 3 endometrioid carcinoma

- Endometrial carcinosarcoma

- Clinical stage I grade 1-2 endometrial cancer also eligible with deep myoinvasion
≥ 50% shown on preop MRI and/or elevated preop CA-125 > 35 U/ml.

- Age ≥18 years

- Hemoglobin ≥10 g/dL

- Plasma albumin ≥3 g/dL

- GOG performance status ≤2

- Plasma glucose ≤200 mg/dL

- Plasma creatinine ≤1.6

- Well-controlled hypertension

- Medical clearance for surgery and considered an appropriate surgical candidate

- Negative serum pregnancy test, if of child-bearing potential

- If, based on surgeon's assessment, the patient is recommended to undergo surgical
staging for histologically confirmed endometrial cancer or if IB1 cervical cancer is
deemed eligible for surgical treatment of disease

- Participation in other research protocols does not exclude a patient from
participation in this study

Exclusion Criteria:

- Hemoglobin <10 g/dL

- Plasma albumin <3 g/dL

- GOG performance status >2

- Plasma glucose >200 mg/dL

- Renal insufficiency with plasma creatinine >1.6

- Uncontrolled hypertension

- Patient does not meet medical clearance for surgery and is not considered an
appropriate surgical candidate

- Pregnancy

For Stage 2:

- Patient who are unwilling or unable to undergo MRI including patients with
contraindications to MRI such as the presence of cardiac pacemakers of non-compatible
intracranial vascular clips, claustrophobia, inability to lie flat for the duration of
the study etc.

- Patients with a metallic hip implant or any other metallic implant or device in the
pelvis that might distort local magnetic field and compromise quality of MRI
We found this trial at
8
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Jennifer Mueller
Phone: 212-639-8229
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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650 Commack Road
Commack, New York 11725
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500 Westchester Avenue
Harrison, New York 10604
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480 Red Hill Road
Middletown, New Jersey 07748
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225 Summit Avenue
Montvale, New Jersey 07645
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1275 York Avenue
Rockville Centre, New York 11570
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Uniondale, New York 11553
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