Diagnostic Imaging for Endometrial Cancer

Not currently recruiting at 6 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Surgery unsafe, Peritoneal metastasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to detect cancer in the lymph nodes of patients with high-risk endometrial cancer, which begins in the lining of the uterus. It employs a PET/CT scan, combining two scan types for a clearer image, and uses a special dye (Indocyanine Green Solution) to locate cancer cells in the lymph nodes. This approach may surpass surgery in identifying cancer spread. Suitable participants have been diagnosed with specific high-grade endometrial cancers and are planning surgery. As an unphased trial, this study allows patients to contribute to innovative research that could enhance cancer detection methods.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, previous hormonal therapy is allowed, and there are no specific instructions about other medications.

What prior data suggests that PET/CT and lymph node mapping are safe for diagnosing endometrial cancer?

Research has shown that indocyanine green (ICG) is safe for mapping lymph nodes in patients with endometrial cancer. Studies have found that patients who received ICG injections did not experience severe allergic reactions or major side effects. Additionally, it has been used safely in patients with certain medical histories.

Positron emission tomography/computed tomography (PET/CT) serves as a reliable and non-invasive method for detecting cancer spread. Studies indicate that patients generally tolerate PET/CT well, and it is already widely used to diagnose other conditions.

In summary, previous research considers both ICG and PET/CT safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to diagnose and map endometrial cancer more effectively. Standard procedures often rely on traditional imaging techniques and surgical exploration, which can be limited in precision. This trial combines PET/CT imaging with an innovative lymph node mapping technique using indocyanine green solution, which offers a more detailed view of lymph node involvement. This approach could lead to more accurate surgical planning and potentially better outcomes for patients by precisely targeting affected areas.

What evidence suggests that PET/CT and lymph node mapping are effective for detecting lymph node metastasis in endometrial cancer?

In this trial, participants will undergo diagnostic imaging using both indocyanine green solution and positron emission tomography combined with computed tomography (PET/CT). Research has shown that indocyanine green solution effectively identifies sentinel lymph nodes in patients with endometrial cancer, outperforming other dyes, such as blue dye, in detecting lymph nodes that might contain cancer cells. This makes it a valuable tool for identifying cancer spread in lymph nodes. Meanwhile, PET/CT scans have demonstrated superior results in detecting cancer in lymph nodes compared to CT alone, offering more effective detection of cancer spread. Both methods in this trial aim to provide clearer images and more accurate detection without requiring surgery. ^{2 4 5 6 7}

Who Is on the Research Team?

Pamela T. Soliman

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had hormone therapy before.

I am not pregnant or of child-bearing age.

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

Exclusion Criteria

Your medical condition does not match the specific type required for the study.

My doctor says surgery is too risky for me due to other health issues.

You need to have a standard test of kidney function before the study starts.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic

Patients undergo PET/CT prior to surgery to identify lymph node metastasis

1 week

1 visit (in-person)

Surgical Staging

Patients undergo intraoperative lymph node mapping with indocyanine green solution during full lymphadenectomy

1 week

1 visit (in-person)

Follow-up

Participants are monitored for post-operative complications and effectiveness of the diagnostic procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Indocyanine Green Solution
• Positron Emission Tomography

Trial Overview

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.

How Is the Trial Designed?

Group I: Diagnostic (PET/CT, lymph node mapping) Experimental Treatment 6 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

(18)F-FDG PET imaging shows high specificity (89.8%) for detecting primary endometrial cancer lesions, but its sensitivity (81.8%) is relatively low, limiting its effectiveness for initial tumor detection.

The imaging technique is particularly effective for identifying distant metastases, with a sensitivity of 95.7% and specificity of 95.4%, indicating it is a reliable tool for assessing advanced disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of fluorine 18 fluorodeoxyglucose positron emission tomography imaging for detection of primary lesion and staging of endometrial cancer patients: systematic review and meta-analysis of the literature. Kakhki, VR., Shahriari, S., Treglia, G., et al.[2022]

In a study of 1414 patients undergoing sentinel lymph node biopsy for endometrial cancer, there were no reported anaphylactic reactions to indocyanine green (ICG), even among those with a history of iodine or contrast allergies.

The incidence of adverse reactions was low, with only 3 patients experiencing potentially allergic reactions, suggesting that ICG is safe for use in this context, especially when premedication with corticosteroids is applied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy in patients with endometrial cancer and an indocyanine green or iodinated contrast reaction - A proposed management algorithm. Zammarrelli, WA., Afonso, AM., Broach, V., et al.[2022]

In a study involving 4 colorectal cancer patients with peritoneal carcinomatosis, the use of indocyanine green fluorescence imaging (ICG-FI) significantly improved the detection of cancerous nodules during surgery, increasing sensitivity from 76.9% to 96.9%.

ICG-FI demonstrated high accuracy with a positive predictive value of 98.4% and helped identify 17 additional metastatic nodules that were not detected by conventional imaging methods, suggesting it could enhance surgical outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorescence-Guided Surgery in the Combined Treatment of Peritoneal Carcinomatosis from Colorectal Cancer: Preliminary Results and Considerations. Lieto, E., Auricchio, A., Cardella, F., et al.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4889617/

Impact of Indocyanine Green for Sentinel Lymph Node ...

ICG was significantly superior to 99m Tc with blue dye in terms of bilateral OM in women with early stage endometrial and cervical cancer.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1048891X24159439

EV116/#458 Effectiveness of indocyanine green ...

This retrospective study analyzed 13 endometrial cancer patients who underwent SLN mapping with ICG fluorescence imaging at an oncology center in Salvador, ...

3.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS5638

Evaluation of indocyanine green (ICG) and handheld ...

This research plans to assess hand-held fluorescence imager using ICG dye for feasibility, ergonomics, accuracy and applicability in all gynecologic cancers.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02131558

Study Details | NCT02131558 | Indocyanine Green and ...

The primary outcome is to determine whether sentinel lymph nodes (SLN) were accurately visualized using Indocyanine green (ICG) and near-infrared (NIR) imaging.

5.

bmcsurg.biomedcentral.com

bmcsurg.biomedcentral.com/articles/10.1186/s12893-025-03232-w

Comparison of identification of sentinel lymph nodes between ...

This study aimed to assess the comparative effectiveness of indocyanine green and methylene blue in the marking and identification of ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S1048891X24013136

Let go of the myth: safety of indocyanine green for sentinel ...

Indocyanine green injection for sentinel lymph node mapping in patients with endometrial cancer caused no immediate/delayed anaphylactic or other severe ...

7.

international-journal-of-gynecological-cancer.com

international-journal-of-gynecological-cancer.com/article/S1048-891X(25)00334-2/fulltext

#311 Safety of indocyanine green (ICG) for sentinel lymph ...

The use of ICG for intracervical injection in SLN mapping is safe. ICG safety profile is confirmed even in the subset of patients with a history of ...