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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

Must not have

Evidence of peritoneal or distant metastasis on preoperative imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of surgery

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My scans show cancer has spread to my abdomen or further.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

False negative rate of sentinel lymph node mapping

Secondary study objectives

CA-125 levels

Concordance for each procedure and for the combination of both procedures

HE4 levels

+7 more

Side effects data

From 2019 Phase 2 trial • 24 Patients • NCT02509598

17%

Nausea

13%

Vomiting

febrile neutropenia

Anaemia

hypokalaemia

acute kidney injury

pyrexia

100%

80%

60%

40%

20%

Study treatment Arm

Tc99m Tilmanocept and Vital Blue Dye (Optional)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2740

Lymph Node Mapping

2015

Completed Phase 2

~50