PET Imaging with 18F-FDG for Cervical Cancer

Recruiting at 7 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Renal insufficiency, Uncontrolled hypertension, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

42 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment 18F-FDG PET/CT and PET/MRI imaging for cervical cancer?

Research shows that 18F-FDG PET imaging is better than traditional CT and MRI scans at detecting recurrent cervical cancer and understanding how far it has spread. This helps doctors make better treatment decisions for patients with cervical cancer. ^{1 2 3 4 5}

Is 18F-FDG PET imaging safe for humans?

The studies focus on the use of 18F-FDG PET imaging for cervical cancer, but they do not provide specific safety data. Generally, 18F-FDG PET imaging is considered safe for humans, as it is widely used in medical imaging for various conditions. ^{3 6 7 8 9}

How does PET imaging with 18F-FDG differ from other treatments for cervical cancer?

PET imaging with 18F-FDG is unique because it uses a special type of scan to help diagnose and manage cervical cancer by highlighting cancerous areas in the body. Unlike traditional treatments that focus on directly treating the cancer, this imaging technique helps doctors see how far the cancer has spread, which can guide treatment decisions. ^{6 7 8 10 11}

Research Team

Jennifer Mueller, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for women over 18 with stage IB1 cervical cancer or high-grade endometrial cancer, who are fit for surgery and have controlled blood pressure. They must not be pregnant, have a hemoglobin level of at least 10 g/dL, albumin of at least 3 g/dL, glucose under 200 mg/dL, creatinine under 1.6 mg/dL, and no severe health conditions that would interfere with an MRI.

Inclusion Criteria

I am a woman with early-stage cervical cancer eligible for surgery.

I have stage I high-grade endometrial cancer and plan to have surgery.

My endometrial cancer is early stage but aggressive, shown by MRI or high CA-125 levels.

Exclusion Criteria

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

I cannot have an MRI due to a medical condition or device, or because I can't lie flat.

Plasma glucose >200 mg/dL

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgical Imaging

Participants undergo intracervical 18F-FDG injection during a dynamic PET/CT scan to map lymph nodes before surgery

1 day

1 visit (in-person)

Surgery and Standard Care

Participants receive standard peri- and postoperative care following the imaging procedure

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• 18F-Fluorodeoxyglucose (18F-FDG)
• PET/CT imaging
• PET/MRI imaging

Trial Overview The study tests if injecting a radioactive substance called 18F-FDG into the cervix before surgery can better identify which pelvic lymph nodes contain cancer using PET/CT or PET/MRI imaging techniques.

Participant Groups

Group I: intracervical 18F-FDG injection during a dynamic PET/CT Experimental Treatment 3 Interventions

The first 20 eligible patients will be consented to undergo intracervical 18F-FDG injection during a dynamic PET/CT scan. Study enrollment will occur in the clinic during the visit in which they are consented for surgery. Recruited patients will undergo 18F-FDG-guided PET imaging on the day of their scheduled staging surgery. The experimental PET/CT is anticipated to take 2 hours. The second stage of accrual will replace PET/CT with PET/MRI imaging. In every other aspect, patients will receive standard peri- and postoperative care.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

In a study of 36 patients with suspected recurrent cervical cancer, FDG-PET imaging detected more metastatic sites in 56% of cases compared to conventional imaging methods, highlighting its superior diagnostic capability.

FDG-PET results significantly influenced treatment plans, leading to changes in treatment modality for 33% of patients and a shift from curative to palliative intent in 30% of cases, demonstrating its critical role in clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of 2-deoxy-2-[18F]fluoro-D-glucose (FDG)-positron emission tomography (PET) on treatment choice in recurrent cancer of the cervix uteri. Bjurberg, M., Brun, E.[2018]

In a study of 54 patients with cervical carcinoma, the hybrid 18F-FDG PET/MRI technique demonstrated a significant correlation between tumor glucose metabolism (measured by SUVmax and SUVmean) and various functional MRI metrics, indicating its potential for assessing tumor heterogeneity.

The study found that specific MRI parameters (R2*, f, and D) can provide insights into the tumor's hypoxic conditions and blood perfusion, suggesting that this multimodal imaging approach could enhance the understanding and diagnosis of cervical cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation between tumor glucose metabolism and multiparametric functional MRI (IVIM and R2*) metrics in cervical carcinoma: Evidence from integrated 18 F-FDG PET/MR. Li-Ou, Z., Hong-Zan, S., Xiao-Xi, B., et al.[2020]

In a study of 60 cervical cancer patients, (18)FDG PET imaging was found to be effective in detecting extrapelvic metastases, identifying 9 unsuspected nodal sites that MRI missed, which influenced treatment decisions in 18% of cases.

While PET was superior in diagnosing recurrent disease in patients with negative or unclear conventional imaging, MRI remained more effective for assessing the local spread of the tumor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contribution of whole-body 18FDG PET imaging in the management of cervical cancer. Belhocine, T., Thille, A., Fridman, V., et al.[2022]

FDG PET scans were successfully performed on 21 patients with cervical cancer, detecting 76% of newly diagnosed or recurrent cases, indicating its feasibility and potential effectiveness in identifying these cancers.

The use of postvoid imaging significantly improved the detection rate, allowing for 100% detection of cancers in patients scanned this way, and FDG PET was more effective than CT in identifying lymph node metastases, detecting 86% compared to CT's 57%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of FDG PET in patients with cervical cancer. Sugawara, Y., Eisbruch, A., Kosuda, S., et al.[2016]

In a study of 135 patients with locally advanced or recurrent cervical cancer, dual-phase FDG-PET was found to be significantly more effective than MRI-CT in identifying metastatic lesions, with an area under the curve (AUC) of 0.951 compared to 0.879 for MRI-CT.

The dual-phase FDG-PET not only improved detection rates of metastatic lesions (90% vs. 70% for conventional PET) but also influenced treatment decisions for 31% of patients, indicating its potential to enhance clinical management of cervical cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of dual-phase 2-fluoro-2-deoxy-d-glucose positron emission tomography in cervical cancer. Yen, TC., Ng, KK., Ma, SY., et al.[2016]

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical impact of 2-deoxy-2-[18F]fluoro-D-glucose (FDG)-positron emission tomography (PET) on treatment choice in recurrent cancer of the cervix uteri. [2018]

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

Clinical impact of integrated PET/CT on the management of suspected cervical cancer recurrence. [2022]

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

Correlation between tumor glucose metabolism and multiparametric functional MRI (IVIM and R2*) metrics in cervical carcinoma: Evidence from integrated 18 F-FDG PET/MR. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Relative clinical utility of simultaneous 18F-fluorodeoxyglucose PET/MRI and PET/CT for preoperative cervical cancer diagnosis. [2021]

5. Singapore pubmed.ncbi.nlm.nih.gov

Molecular imaging in the management of cervical cancer. [2016]

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

Contribution of whole-body 18FDG PET imaging in the management of cervical cancer. [2022]

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

Evaluation of FDG PET in patients with cervical cancer. [2016]

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

Value of dual-phase 2-fluoro-2-deoxy-d-glucose positron emission tomography in cervical cancer. [2016]

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

18F-FDG-PET/CT is of limited value in primary staging of early stage cervical cancer. [2016]

10. China pubmed.ncbi.nlm.nih.gov

Application value of 18F-FDG PETCT imaging in the clinical initial diagnosis and follow-up of primary lesions of cervical cancer. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Diagnostic Value of 18F-FDG PET/MRI for Revised 2018 FIGO Staging in Patients with Cervical Cancer. [2021]