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 |
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.
(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
480 Red Hill Road
Middletown, New Jersey 07748
Middletown, New Jersey 07748
Phone: 212-639-8229
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
Basking Ridge, New Jersey 07920
Phone: 212-639-8229
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650 Commack Road
Commack, New York 11725
Commack, New York 11725
Phone: 212-639-8229
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500 Westchester Avenue
Harrison, New York 10604
Harrison, New York 10604
Phone: 212-639-8229
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225 Summit Avenue
Montvale, New Jersey 07645
Montvale, New Jersey 07645
Phone: 212-639-8229
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1275 York Ave
New York, New York 10021
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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1275 York Avenue
Rockville Centre, New York 11570
Rockville Centre, New York 11570
Phone: 212-639-8229
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