FDG-PET Guided Radiation for Gastrointestinal and Gynecologic Cancers

Overseen By Eileen Duffy, RN BSN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Duke University

Disqualifiers: No visible disease, Breastfeeding, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

90 Participants Needed

Trial Summary

What is the purpose of this trial?

This study expands on protocol (NCT01908504"PET adaptive RT") designed to evaluate the utility of adaptive PET-CT planning for radiation therapy (RT). Radiation therapy is used in many malignant diseases as a curative treatment modality. However, critical normal tissue is often in close approximation to disease, and portions of such tissue must receive high doses of radiation for appropriate treatment. Positron Emission Tomography (PET) adapted radiation therapy, as defined in the current protocol, may allow for a means of determining the eventual response to therapy, at a time point when adaptation of treatment plan may be possible to improve outcomes. This protocol will build upon the findings the previous protocol (NCT01908504 "PET adaptive RT") that evaluated the utility of intra-treatment PET imaging in multiple types of cancers. The current focus will be more specific to certain types of gastrointestinal and gynecologic cancers treated with RT, identified from the prior study to warrant further research.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more information.

Will I have to stop taking my current medications?

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 idea that FDG-PET Guided Radiation for Gastrointestinal and Gynecologic Cancers is an effective treatment?

The available research shows that FDG-PET Guided Radiation is effective for gastrointestinal and gynecologic cancers. For gastrointestinal cancers, FDG-PET is particularly good at detecting and staging recurrent colorectal cancer, with a high accuracy rate. It is also effective in diagnosing pancreatic cancer when a suspicious mass is seen on a CT scan. For gynecologic cancers, FDG-PET is used in planning radiation treatment for cervical, vulvar, and vaginal cancers, and it helps in evaluating the treatment's success. Compared to other methods, FDG-PET is more accurate in detecting certain types of cancer spread, which can lead to better treatment planning and outcomes. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment FDG-PET Guided Radiation for Gastrointestinal and Gynecologic Cancers?

FDG-PET scans are effective in diagnosing and managing gastrointestinal and gynecologic cancers by helping to detect cancer recurrence and stage the disease. They are also useful in planning radiation treatment and evaluating how well the treatment is working, which can help tailor therapy to individual patients. ^{1 2 3 4 5}

What safety data exists for FDG-PET guided radiation treatment?

The safety data for FDG-PET guided radiation treatment includes the potential for immune-related adverse events (irAEs) that can be detected on 18F-FDG PET/CT imaging, particularly affecting the endocrine, cutaneous, and gastrointestinal systems. Additionally, there is a reported case of an allergic reaction to fluorodeoxyglucose used in PET/CT scans. It is important to differentiate between treatment-related effects and disease to manage these adverse events effectively. ^{6 7 8 9 10}

Is FDG-PET generally safe for humans?

FDG-PET is generally safe, but there have been rare reports of allergic reactions to the radiotracer used in the scans. Additionally, it can help detect immune-related side effects in patients undergoing certain cancer treatments. ^{6 7 8 9 10}

Is FDG-PET Guided Radiation a promising treatment for gastrointestinal and gynecologic cancers?

Yes, FDG-PET Guided Radiation is promising because it helps doctors see cancer more clearly, which can improve treatment planning and monitoring. It is especially useful for detecting cancer spread and checking how well treatment is working, making it a valuable tool in treating gastrointestinal and gynecologic cancers. ^{2 3 4 11 12}

How is FDG-PET guided radiation treatment different for gastrointestinal and gynecologic cancers?

FDG-PET guided radiation treatment is unique because it uses a special imaging technique to better target cancer cells by detecting areas with high glucose uptake, which is common in tumors. This approach helps in planning radiation therapy more precisely, potentially improving treatment outcomes by focusing on cancerous tissues while sparing healthy ones. ^{2 3 4 11 12}

Research Team

Junzo Chino, MD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for adults over 18 with certain types of cancer (cervical, vulvar, esophageal, anal) who are not pregnant or breastfeeding. They must have a performance status indicating they can carry out daily activities with ease or with some limitation and visible disease on imaging before radiotherapy.

Inclusion Criteria

My cancer diagnosis is confirmed for cervical, vulvar, esophageal, or anal canal.

I can take care of myself and am up and about more than 50% of my waking hours.

I have signed or will sign the consent form for this study.

Exclusion Criteria

Breastfeeding

Positive serum pregnancy test

No gross disease visible on imaging at the start of radiotherapy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants undergo radiation therapy with adaptive PET-CT planning to evaluate and potentially adjust treatment plans

3-5 weeks

2 research PET scans, multiple radiation therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with regular follow-up imaging and evaluations

4 years

Treatment Details

Interventions

• FDG PET scan

Trial Overview The study tests if PET scans during radiation therapy can help adapt the treatment plan to improve outcomes for patients with specific gastrointestinal and gynecologic cancers. It builds upon previous research suggesting benefits of intra-treatment PET imaging.

Participant Groups

Group I: Single arm interventional study Experimental Treatment 1 Intervention

Research FDG-PET scan obtained before radiation therapy; a second research FDG-PET scan is obtained at about 3-5 weeks after treatment has started.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

FDG-PET is a valuable tool for assessing locally advanced gastrointestinal cancers and for detecting recurrences, enhancing diagnostic accuracy when combined with CT imaging.

The use of FDG-PET is expanding to include treatment response evaluation and prognosis prediction, with ongoing development of new PET probes aimed at personalizing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positron emission tomography for the diagnosis and management of patients with gastrointestinal malignancies. Saga, T., Nakamoto, Y., Higashi, T., et al.[2016]

Fluorine-18-fluorodeoxyglucose (FDG)-PET/CT is recommended for baseline assessment in cervical cancer and for staging in vulvar and vaginal cancers, highlighting its importance in the initial evaluation of these gynecologic malignancies.

FDG-PET/CT is also valuable in planning definitive and salvage radiation treatments for recurrent gynecologic cancers, and it has supportive data for use in posttreatment evaluations, particularly for cervical and vulvar cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of PET Imaging in Gynecologic Radiation Oncology. Rao, YJ., Grigsby, PW.[2018]

Incorporating 18F-FDG PET CT in radiotherapy planning for gynecological cancers can reduce variability among different observers when defining treatment targets, leading to more accurate treatment plans.

This imaging technique provides important functional information about tumors, which can help in developing advanced treatment strategies like dose escalation and 'dose painting', particularly beneficial for patients with locally advanced cervical cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Use of 18F-FDG PET CT for External Beam Radiotherapy Planning in Gynaecological Malignancies. Kerr, A., Reed, N., Harrand, R., et al.[2019]

FDG-PET scanning is a highly effective diagnostic tool for gastrointestinal cancers, particularly in staging oesophageal carcinoma and detecting recurrence in colorectal carcinoma, with sensitivity rates reaching up to 100%.

The technique is also valuable for differentiating between benign and malignant pancreatic lesions, showing high sensitivity and specificity, making it a crucial part of cancer diagnosis and treatment monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDG-PET scanning in the diagnosis of gastrointestinal cancers. van Kouwen, MC., Oyen, WJ., Nagengast, FM., et al.[2019]

Using PET scans with the glucose analog [18F]-FDG can effectively monitor how well tumors respond to chemotherapy and chemoradiotherapy, particularly in gastrointestinal cancers.

FDG PET can help differentiate between remaining tumor tissue and therapy-induced fibrosis, and it may predict patient outcomes early in treatment, allowing for timely adjustments in therapy for nonresponders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapy Monitoring with Fluorine-18 FDG-PET and Fluorine-18 FDG-PET/CT. Wieder, HA., Herrmann, K.[2016]

18F-Fluorodeoxyglucose PET/CT imaging is crucial for assessing cancer treatment, including staging and monitoring responses, especially in patients undergoing immunotherapy.

The review highlights the importance of recognizing immune-related adverse events (irAEs) that can appear on imaging, as early detection is vital for effective management and to avoid misinterpreting treatment effects as disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy-related adverse effects on 18F-FDG PET/CT imaging. Gandy, N., Arshad, MA., Wallitt, KL., et al.[2021]

Positron emission tomography (PET) using (18)F-fluoro-2-deoxyglucose (FDG) is becoming more valuable for assessing gastrointestinal cancers.

This imaging technology helps in the evaluation of malignancies, potentially improving diagnosis and treatment planning for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-Fluoro-2-deoxyglucose positron emission tomography in the evaluation of gastrointestinal malignancies. Chin, BB., Wahl, RL.[2019]

PET/CT imaging, particularly with the radiotracer 18F-FDG, is crucial in managing gastrointestinal cancers, but its variable uptake in the bowel can complicate interpretations, especially in the presence of benign conditions that mimic malignancies.

Awareness of common patterns of radiotracer biodistribution and potential artifacts is essential for accurate diagnosis, as certain benign conditions and post-treatment changes can lead to intense uptake that may obscure true malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variants and Pitfalls in PET/CT Imaging of Gastrointestinal Cancers. Jayaprakasam, VS., Paroder, V., Schöder, H.[2023]

In a study of 46 patients undergoing immunotherapy for various cancers, 61% developed immune-related adverse events (irAEs) detectable by 18F-FDG PET/CT, highlighting its importance in monitoring treatment effects.

The most common irAE detected was enteritis/colitis, occurring in 28.2% of patients, indicating that PET/CT can effectively identify significant inflammatory responses associated with immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic impact of 18F-FDG PET/CT imaging on the detection of immune-related adverse events in patients treated with immunotherapy. Tatar, G., Alçin, G., Sengul Samanci, N., et al.[2022]

This study highlights the first reported case of an allergic reaction to fluorodeoxyglucose, a radiopharmaceutical used in PET/CT scans, in a patient undergoing repeated scans for pyriform sinus cancer.

As the use of PET/CT procedures increases, it is crucial to understand and manage potential adverse effects, such as allergic reactions, to ensure patient safety during these diagnostic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorodeoxyglucose-induced allergic reaction: a case report. Codreanu, I., Dasanu, CA., Weinstein, GS., et al.[2019]

FDG-PET is a valuable imaging technique for staging and monitoring gastrointestinal tumors, particularly effective in detecting distant metastases in esophageal and gastric cancer, which can prevent unnecessary surgeries.

It is also useful for assessing therapy responses in rectal carcinoma and monitoring other gastrointestinal cancers, although it has limitations in lymph node staging and is not sufficient for certain liver cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[[18F]-FDG-PET in the diagnostics of gastrointestinal tumors]. Buchmann, I., Ganten, TM., Haberkorn, U.[2016]

FDG-PET/CT is an effective imaging technique for staging, assessing treatment response, and diagnosing recurrent cervical and ovarian cancers.

The potential applications of FDG-PET/CT in other gynecologic cancers, such as endometrial cancer and uterine sarcomas, remain under-researched, indicating a need for further exploration in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET/CT Imaging in Gynecologic Malignancies Other than Ovarian and Cervical Cancer. Bhosale, P., Iyer, R., Jhingran, A., et al.[2016]

References

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

Positron emission tomography for the diagnosis and management of patients with gastrointestinal malignancies. [2016]

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

The Role of PET Imaging in Gynecologic Radiation Oncology. [2018]

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

Evaluating the Use of 18F-FDG PET CT for External Beam Radiotherapy Planning in Gynaecological Malignancies. [2019]

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

FDG-PET scanning in the diagnosis of gastrointestinal cancers. [2019]

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

Therapy Monitoring with Fluorine-18 FDG-PET and Fluorine-18 FDG-PET/CT. [2016]

6. England pubmed.ncbi.nlm.nih.gov

Immunotherapy-related adverse effects on 18F-FDG PET/CT imaging. [2021]

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

18F-Fluoro-2-deoxyglucose positron emission tomography in the evaluation of gastrointestinal malignancies. [2019]

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

Variants and Pitfalls in PET/CT Imaging of Gastrointestinal Cancers. [2023]

9. Italy pubmed.ncbi.nlm.nih.gov

Diagnostic impact of 18F-FDG PET/CT imaging on the detection of immune-related adverse events in patients treated with immunotherapy. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Fluorodeoxyglucose-induced allergic reaction: a case report. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

[[18F]-FDG-PET in the diagnostics of gastrointestinal tumors]. [2016]

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

PET/CT Imaging in Gynecologic Malignancies Other than Ovarian and Cervical Cancer. [2016]