Early Prediction of Pathology Response of Chemoradiotherapy With FLT PET
| Status: | Terminated |
|---|---|
| Conditions: | Lung Cancer, Cancer, Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/28/2017 |
| Start Date: | August 2009 |
| End Date: | February 2013 |
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.
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.
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.
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.
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
We found this trial at
1
site
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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