Early Prediction of Pathology Response of Chemoradiotherapy With FLT PET
Study Details
Study Description
Brief Summary
The goal of this research study is to learn if a new type of PET scan (18F-FLT) can help to better detect changes of tumor growth rate (or how active) in esophagus cancer and lung cancer Researchers will study at what time during treatment the 18F-FLT PET scan should be given to get the best results. A Positron Emission Tomography (PET) scan is a type of scan that uses a radioactive solution to locate cancer cells inside the body. Using the PET scan, doctors can locate solid tumors and collect information about how "active" the cancer cells are. For this study, a new type of solution, [F-18]-fluoro-L-thymidine (FLT), will be used. FLT can detect actively growing tumor, and researchers hope that FLT may be able to help provide information about how well esophagus cancer treatment is working. This information could be used to help predict if the cancer will respond to treatment.
All enrolled subjects will receive PET/CT imaging at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy (3 weeks from the start of Neoadjuvant Therapy) prior to the surgery. At each time of the PET/CT procedure, the subject will receive an injection of FLT which is an investigational pharmaceutical labeled with radioactive fluorine. 45-60 mines after the FLT injection, the scan will be performed. Each scan might take 10-15 minutes. Participation in this pilot study will not change the patients normal chemotherapy, radiation treatment, and surgery recommended the patients physician as parts of their standard of care.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
The goal of the study is to obtain preliminary data and initial estimates of the FLT ability-PET to identify pathCR patients who have esophageal carinoma or non-small cell lung cancer and undergo Neoadjuvant Therapy (Chemoradiotherapy, Chemotherapy or Radiation Therapy) prior to surgery. Achievement in pathCR after pre-operative Neoadjuvant Therapy is associated with improved patient outcomes; however, there is no effective method to predict pathological response before surgery. Thus, a patient with pathCR , for whom esophagectomy or thoracoscopy may be unnecessary, still undergoes surgery and faces the prohibitive side effects of this surgical procedure. Additionally, Neoadjuvant Therapy is associated with considerable morbidities and tool to predict and avoid ineffective therapy are lacking. Because deregulated proliferation is one of the hallmarks of cancer and its proliferation rate is associated with aggressive biologic behavior and response to therapy, imaging the proliferative state of cancer cells by non-invasive functional imaging is of great interest. Recently 18F-FLT (3'deoxy33'-18F- fluorothymidine) has been reported as a promising PET radiopharmaceutical for imaging cancer proliferation and has been validated in several in vitro & in vivo models. However, only a few studies addressed its role in depicting changes in cancer proliferation and assessing response to Neoadjuvant Therapy, and none of these studies have focused on esophageal cancer and lung cancer. We propose to conduct a pilot study to learn the optimal FLT PET imaging timepoint during the early course of Neoadjuvant Therapy that has the highest predictive value for pathCR in patients with esophageal cancer or lung cancer.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fluoro-L-Thymidine Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery. |
Drug: Fluoro-L-Thymidine
4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Optimal Timepoint During the Course of Neoadjuvant Therapy [CRT, CT (Chemotherapy) or RT Radiotherapy)] That FLT-PET Imaging Can Predict Response [2.5 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients with histologically diagnosed adenocarcinoma or squamous cell carcinoma of the esophagus and locoregional disease (stages II and III) and locally advanced non-small cell lung cancer (stage III) will be eligible for participation in this study.
Exclusion Criteria:
-
Abnormal liver function (<2.5 x ULN of aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ; <1.5 x upper limit of normal (ULN) of bilirubin total) or abnormal renal function (<1.5 x ULN of creatinine) or peripheral neuropathy
-
Women with pregnancy or breastfeeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Columbia University Medical Center | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Columbia University
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: K.S. Clifford Chao, MD, Columbia University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAAD5444
- R21CA121551
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Fluoro-L-Thymidine |
|---|---|
| Arm/Group Description | Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery. Fluoro-L-Thymidine (FLT): 4-dimensional (4D)-Positron Emission Tomography (PET)/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery. |
| Period Title: Overall Study | |
| STARTED | 6 |
| COMPLETED | 4 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Fluoro-L-Thymidine |
|---|---|
| Arm/Group Description | Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery. Fluoro-L-Thymidine: 4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery. Data on age (per age categories) and race/ethnicity was not available for these 6 subjects. Only sex was available. |
| Overall Participants | 6 |
| Age, Customized (Count of Participants) | |
| >18 years |
6
100%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
2
33.3%
|
| Male |
4
66.7%
|
Outcome Measures
| Title | Optimal Timepoint During the Course of Neoadjuvant Therapy [CRT, CT (Chemotherapy) or RT Radiotherapy)] That FLT-PET Imaging Can Predict Response |
|---|---|
| Description | |
| Time Frame | 2.5 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to poor enrollment, data was not analyzed. Adequate data was not collected and the only type of data that remained available was the total # enrolled, some information of the population demographics, and AE/SAE logs that were submitted to the IRB for review. |
| Arm/Group Title | Fluoro-L-Thymidine |
|---|---|
| Arm/Group Description | Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery. Fluoro-L-Thymidine: 4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery. |
| Measure Participants | 0 |
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Fluoro-L-Thymidine | |
| Arm/Group Description | Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery. Fluoro-L-Thymidine: 4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery. Only 5 subjects were followed for AEs/SAEs since one subject withdrew consent prior to any participation in the study. | |
All Cause Mortality |
||
| Fluoro-L-Thymidine | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/5 (0%) | |
Serious Adverse Events |
||
| Fluoro-L-Thymidine | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/5 (60%) | |
| General disorders | ||
| Allergic Reaction to Chemotherapy | 1/5 (20%) | 1 |
| Chest Pain | 1/5 (20%) | 1 |
| Hepatobiliary disorders | ||
| Abnormal Liver Function | 1/5 (20%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Fluoro-L-Thymidine | ||
| Affected / at Risk (%) | # Events | |
| Total | 5/5 (100%) | |
| Blood and lymphatic system disorders | ||
| Abnormal Complete Blood Count (CBC) | 1/5 (20%) | 1 |
| White Blood Cell (WBC) Count Increased | 1/5 (20%) | 1 |
| Ear and labyrinth disorders | ||
| Odynophagia | 1/5 (20%) | 1 |
| Endocrine disorders | ||
| Blood Glucose Level Increased | 1/5 (20%) | 1 |
| Hepatobiliary disorders | ||
| ALT Increased | 1/5 (20%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | K.S. Clifford Chao, MD |
|---|---|
| Organization | Columbia University |
| Phone | 212-305-9987 |
| ksc2119@cumc.columbia.edu |
- AAAD5444
- R21CA121551