Diagnostic Imaging for Endometrial Cancer

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

150 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Indocyanine Green Solution, IC-Green, Cardio-Green, Fox Green, ICG, Positron Emission Tomography, PET, Positron Emission Tomography, PET/CT, PET Scan for endometrial cancer?

Research shows that PET/CT scans are valuable in evaluating endometrial cancer, especially for detecting recurrent disease and assessing the extent of cancer spread, which helps in planning treatment. This imaging technique is effective in comparison to conventional imaging methods, providing important information for managing endometrial cancer. ^{1 2 3 4 5}

Is indocyanine green safe for use in diagnostic imaging for endometrial cancer?

Indocyanine green (ICG) is generally safe for use in sentinel lymph node mapping for endometrial cancer, with adverse reactions being extremely rare. It has an excellent safety profile compared to other dyes and is preferred for its ease of use and effectiveness. ^{6 7 8 9 10}

How does the treatment for endometrial cancer using indocyanine green differ from other treatments?

This treatment uses indocyanine green (ICG), a special dye, to help identify sentinel lymph nodes during surgery, which can reduce the need for more extensive lymph node removal and potentially lower the risk of complications compared to traditional methods. ^{9 11 12 13 14}

What is the purpose of this trial?

This clinical trial studies positron emission tomography (PET)/computed tomography (CT) and lymph node mapping in finding lymph node metastasis in patients with endometrial cancer that is at high risk of spreading. A PET/CT scan is a procedure that combines the pictures from a PET scan and a CT scan, which are taken at the same time from the same machine. The combined scans give more detailed pictures of areas inside the body than either scan gives by itself. Lymph node mapping uses a radioactive dye, called indocyanine green solution, to identify lymph nodes that may contain cancer cells. PET/CT and sentinel lymph node mapping may be better ways than surgery to identify cancer in the lymph nodes.

Research Team

Pamela T. Soliman

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

(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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Clinical and prognostic value of 18F-FDG PET/CT in recurrent endometrial carcinoma. [2022]

2. Turkey pubmed.ncbi.nlm.nih.gov

Role of positron emission tomography-computed tomography in endometrial cancer. [2022]

3. Spain pubmed.ncbi.nlm.nih.gov

The value of FDG-PET/CT in the post-treatment evaluation of endometrial carcinoma: a comparison of PET/CT findings with conventional imaging and CA 125 as a tumour marker. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Role of imaging in the routine management of endometrial cancer. [2020]

5. England 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. [2022]

6. United States 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Let go of the myth: safety of indocyanine green for sentinel lymph node mapping in endometrial cancer. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Sentinel lymph node mapping in endometrial cancer: comparison of fluorescence dye with traditional radiocolloid and blue. [2018]

9. Belgium pubmed.ncbi.nlm.nih.gov

Sentinel-lymph-node mapping with indocyanine green in robotic-assisted laparoscopic surgery for early endometrial cancer: a retrospective analysis. [2022]

10. Ireland pubmed.ncbi.nlm.nih.gov

The safety and feasibility of minimally invasive sentinel lymph node staging using indocyanine green in the management of endometrial cancer. [2018]

11. Czech Republic pubmed.ncbi.nlm.nih.gov

Sentinel lymph node mapping in endometrial cancer - robotic vs. laparoscopic detection system. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Sentinel node mapping with indocyanine green and endoscopic near-infrared fluorescence imaging in endometrial cancer. A pilot study and review of the literature. [2015]

13. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic Indocyanine Green Sentinel Lymph Node Mapping in Endometrial Cancer. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

Fluorescence-Guided Surgery in the Combined Treatment of Peritoneal Carcinomatosis from Colorectal Cancer: Preliminary Results and Considerations. [2019]