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Diagnostic Imaging for Endometrial Cancer

N/A

Waitlist Available

Led By Pamela Soliman

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Negative pregnancy test if of child-bearing age

Patients with a grade 1/2 tumors and evidence of deep myometrial invasion or cervical involvement on preoperative imaging or physical exam

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of surgery

Awards & highlights

Study Summary

This trial is testing if PET/CT and lymph node mapping can help find cancer in patients with endometrial cancer who are at high risk for the cancer spreading.

Who is the study for?

This trial is for patients with high-risk endometrial cancer, including specific types like grade 3 endometrioid, serous, and clear cell cancers. Candidates must be suitable for surgery, have no prior treatment for their cancer except hormonal therapy, and show no signs of disease spread in the abdomen on scans. Women of childbearing age need a negative pregnancy test.Check my eligibility

What is being tested?

The study is testing if PET/CT scans combined with lymph node mapping using indocyanine green solution can better detect cancer in lymph nodes compared to traditional surgical methods. This could potentially improve diagnosis without needing immediate surgery.See study design

What are the potential side effects?

Possible side effects include reactions to the radioactive dye used in lymph node mapping or issues related to CT scan contrast agents such as allergic reactions or kidney problems. The procedure may also cause discomfort at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant or of child-bearing age.

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My tumor is grade 1 or 2 and has spread deeply into the muscle of my uterus or to my cervix.

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I have not received any treatment for endometrial cancer before surgery.

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I am eligible for surgery.

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My endometrial cancer is confirmed to be a high grade type.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

False negative rate of positron emission tomography (PET)/computed tomography (CT)

False negative rate of sentinel lymph node mapping

Secondary outcome measures

CA-125 levels

Concordance for each procedure and for the combination of both procedures

HE4 levels

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (PET/CT, lymph node mapping)Experimental Treatment6 Interventions

Patients undergo PET/CT prior to surgery. Patients then undergo intraoperative lymph node mapping with indocyanine green solution, given via superficial and deep cervical injection during full lymphadenectomy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2720

Lymph Node Mapping

2015

Completed Phase 2

~30

Lymphadenectomy

2021

Completed Phase 2

~1480

Indocyanine Green Solution

2018

N/A

~150

Positron Emission Tomography

2008

Completed Phase 2

~2240

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,971 Previous Clinical Trials

1,787,066 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,339 Total Patients Enrolled

Pamela SolimanPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Lymph Node Mapping Clinical Trial Eligibility Overview. Trial Name: NCT01737619 — N/A

Endometrial Adenocarcinoma Research Study Groups: Diagnostic (PET/CT, lymph node mapping)

Endometrial Adenocarcinoma Clinical Trial 2023: Lymph Node Mapping Highlights & Side Effects. Trial Name: NCT01737619 — N/A

Lymph Node Mapping 2023 Treatment Timeline for Medical Study. Trial Name: NCT01737619 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaged in this investigation?

"Unfortunately, this experiment is now closed to new participants. Initially posted on April 3rd 2013 and most recently edited on May 4th 2022, enrolment for this trial has ended. There are currently 1112 clinical trials recruiting patients who have endometrial neoplasms and 30 studies requiring volunteers with lymph node mapping experience."

Answered by AI

How many sites are currently conducting this clinical investigation?

"The trial is presently active across 7 sites, including Lyndon Baines Johnson General Hospital in Houston, M D Anderson Cancer Center in Sugar Land, and MD Anderson Regional Care Center-Sugar Land at Nassau Bay. Moreover, there are 4 additional clinical locations involved with this medical research."

Answered by AI

Are there any slots still available in this research endeavor?

"This medical trial is no longer actively recruiting participants. Initially posted on April 3rd 2013, the study was last updated May 4th 2022. However, there are 1112 trials currently enrolling patients with endometrial neoplasms and 30 studies for Lymph Node Mapping that could be of interest to you."

Answered by AI

What is the intention of this experiment?

"This clinical trial's principal objective is to assess the false negative rate of positron emission tomography (PET)/computed tomography (CT). Secondary outcomes include Logistic regression models being employed to measure the odds ratio associated with CA-125 levels, HE4 levels and other metabolic parameters including tumor intensity, metabolic tumour volume and total lesion glycolysis. Additionally, sensitivity and positive predictive value for each procedure as well as a combination of both will be estimated using pathologic findings as the gold standard. These correlations will also be observed with 95% confidence intervals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PET/CT and Lymph Node Mapping in Finding Lymph Node Metastasis in Patients With High-Risk Endometrial Cancer

2013. "PET/CT and Lymph Node Mapping in Finding Lymph Node Metastasis in Patients With High-Risk Endometrial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01737619.

All > Adenocarcinoma > Endometrial Cancer