Clinical trial NCT02285192: Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer
Official title: Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Cervical Cancer
Endometrial Cancer
Keywords: 18F-FDG Injection
Positron Lymphography
Lymphatic Mapping
sentinel lymph nodes
PET/CT
14-222
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2014-11-06
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: diagnostic accuracy of Positron Lymphography
timeFrame: 2 years
Secondary outcomes:
measure: to evaluate several standard uptake value (SUV) (18F-FDG avidity)
timeFrame: 2 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jennifer Mueller, MD
role: PRINCIPAL_INVESTIGATOR
References: