Imaging Biomarker for Esophageal Cancer

Overseen By Steven Lin, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Lactation, Allergic reaction, others

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

Compensation: Varies

Number of Visits: 1

60 Participants Needed

Trial Summary

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.

How does this imaging treatment for esophageal cancer differ from other treatments?

This treatment uses a special imaging technique called FLT-PET, which helps detect early changes in tumor growth after chemoradiotherapy, allowing for more personalized treatment plans. Unlike standard treatments that focus on directly attacking the cancer, this approach focuses on monitoring the cancer's response to therapy. ^{1 2 3 4 5}

What is the purpose of this trial?

To learn if 18F-FAraG PET scans can find tumors in participants with esophageal cancer and predict a participant's response to treatment.

Research Team

Steven H. Lin, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults over 18 with untreated esophageal cancer larger than 2 cm, who will receive chemo and radiation. They must be able to consent, not pregnant or breastfeeding, agree to use birth control, and have a body weight under 400 pounds without conditions preventing imaging.

Inclusion Criteria

Ability to provide written informed consent in accordance with institutional policies

Female participants of childbearing potential must have a negative serum or urine pregnancy test within 1 week of the proposed investigational PET/CT scan(s) prior to injection of the investigational radiopharmaceutical

I have an untreated esophagus cancer larger than 2 cm and will get systemic therapy with radiation.

Exclusion Criteria

Pregnant or lactating females

History of allergic reaction to intravenous contrast

I weigh over 400 pounds or have a condition that prevents me from undergoing certain scans.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Imaging

Participants undergo standard-of-care imaging and 18F-FAraG PET scan before starting treatment

1 week

1 visit (in-person)

Chemoradiation Treatment

Participants receive chemoradiation treatment for esophageal cancer

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ArabinoFuranosylGuanine [18F]F-AraG

Trial Overview The trial is testing if a PET scan using the tracer ArabinoFuranosylGuanine (18F-F-AraG) can detect esophageal tumors and predict how well patients respond to chemoradiation treatment.

Participant Groups

Group I: 18F-FAraG PET Experimental Treatment 1 Intervention

Participants found to be eligible to take part in this study, participant will have a 18F-FAraG PET scan as described below. Before you start treatment, you will have standard-of-care imaging and then undergo the research 18F-FAraG PET scan. About 20 minutes before the injection of the 18F-FAraG imaging tracer, you will drink two 8-ounce bottles of water to help clear the imaging tracer from your kidneys.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

In a study of 24 esophageal cancer patients, a change in tumor volume measured by FDG-PET was the only parameter that effectively identified patients who had a complete response to neoadjuvant therapy after chemoradiation.

Quantitative PET parameters, such as peak and average standardized uptake values, did not differentiate between residual tumors and inflammation caused by treatment, indicating limitations in using these metrics for assessing therapy response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of response to neoadjuvant therapy by quantitative 2-deoxy-2-[18F]fluoro-D-glucose with positron emission tomography in patients with esophageal cancer. Arslan, N., Miller, TR., Dehdashti, F., et al.[2019]

In a study of 52 patients with locally advanced esophageal squamous cell carcinoma, the post-treatment SUVmax of the primary tumor was found to be a significant predictor of achieving pathological complete remission (pCR), although its predictive value was considered modest.

Baseline measurements of total lesion glycolysis and SUVmax of nodal metastases were identified as strong independent predictors of overall survival and recurrence-free survival, highlighting their potential importance in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET/CT in the evaluation of treatment response to neoadjuvant chemoradiotherapy and prognostication in patients with locally advanced esophageal squamous cell carcinoma. Yuan, H., Tong, DK., Vardhanabhuti, V., et al.[2019]

The study found that [18F]fluorodeoxyglucose PET/CT scans performed after the first cycle of chemotherapy did not reliably predict histopathological response in patients with adenocarcinoma of the esophagus, as there was no significant correlation between metabolic changes and tumor viability.

However, in a subgroup of patients who had their PET scans within 16 days of starting chemotherapy, a specific measure called total lesion glycolysis (ΔTLG) showed a significant association with histopathological response, suggesting that ΔTLG could be a potential predictor if assessed early.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18 F]Fluorodeoxyglucose PET/CT and prediction of histopathological response to neoadjuvant chemotherapy for adenocarcinoma of the oesophagus and oesophagogastric junction. Harustiak, T., Zemanova, M., Fencl, P., et al.[2018]

FLT-PET imaging can detect early changes in tumor proliferation in esophageal cancer patients undergoing chemoradiotherapy, showing a significant reduction in tumor uptake of FLT within 24 hours after treatment, which is more pronounced than changes observed with FDG-PET.

The study found a strong correlation between FLT uptake and Ki-67 expression, indicating that FLT-PET is a more specific method for assessing early treatment response compared to FDG-PET, potentially leading to better individualized treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early detection of chemoradioresponse in esophageal carcinoma by 3'-deoxy-3'-3H-fluorothymidine using preclinical tumor models. Apisarnthanarax, S., Alauddin, MM., Mourtada, F., et al.[2016]

In a study of 51 esophageal squamous cell carcinoma (ESCC) patients, higher F-FDG uptake (measured as SUVmax) was significantly correlated with the expression of glucose transporters (GLUT-1 and GLUT-3) and tumor-associated macrophages (CD163), indicating their role in tumor metabolism.

The study found that these molecular markers, along with microvessel density (CD34), are associated with the tumor stage and extent of ESCC, suggesting they may help in understanding the mechanisms behind F-FDG uptake in this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular biological correlation of fluorine-18 fluorodeoxyglucose uptake in esophageal squamous cell carcinoma. Hirose, Y., Kaida, H., Kawahara, A., et al.[2019]

References

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

Evaluation of response to neoadjuvant therapy by quantitative 2-deoxy-2-[18F]fluoro-D-glucose with positron emission tomography in patients with esophageal cancer. [2019]

2. England pubmed.ncbi.nlm.nih.gov

PET/CT in the evaluation of treatment response to neoadjuvant chemoradiotherapy and prognostication in patients with locally advanced esophageal squamous cell carcinoma. [2019]

3. England pubmed.ncbi.nlm.nih.gov

[18 F]Fluorodeoxyglucose PET/CT and prediction of histopathological response to neoadjuvant chemotherapy for adenocarcinoma of the oesophagus and oesophagogastric junction. [2018]

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

Early detection of chemoradioresponse in esophageal carcinoma by 3'-deoxy-3'-3H-fluorothymidine using preclinical tumor models. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Molecular biological correlation of fluorine-18 fluorodeoxyglucose uptake in esophageal squamous cell carcinoma. [2019]