Fludeoxyglucose F 18 PET Imaging in Determining Protein and Gene Expression Signatures in Patients With Premalignant Polyps or Colon Cancer
Pilot Study of Ex-Vivo Molecular Polyp Imaging Using 18-F Fluorodeoxyglucose (FGD) Positron Emission Tomography (PET) in the Determination of Protein and Gene Expression Signatures of Premalignant Polyps
RATIONALE: Diagnostic imaging procedures, such as fludeoxyglucose F 18 PET, may be effective in detecting cancer or recurrence of cancer, or premalignant polyps.
PURPOSE: This clinical trial is studying fludeoxyglucose F 18-PET imaging to see how well it works in determining protein and gene expression signatures in patients with premalignant polyps or colon cancer.
調査の概要
状態
詳細な説明
OBJECTIVES:
Primary
- To determine the feasibility of ex-vivo imaging of colon cancer and colon polyps using fludeoxyglucose F 18 positron emission tomography (FDG PET).
- To evaluate the differences in molecular and genetic profiles between FDG-positive polyps and FDG-negative polyps to suggest what gene mutations and abnormal mRNA and/or protein expressions may be required for FDG avidity ("signature" for FDG avidity).
Secondary
- To evaluate the differences in molecular and genetic profiles between FDG-positive polyps and FDG-positive cancers to suggest what gene mutations and abnormal mRNA and/or protein expressions may be required for cancer formation ("signature" for cancer).
- To evaluate the differences in molecular and genetic profiles between normal colonic mucosa, polyps, and cancer.
- To evaluate the differences and similarities in molecular and genetic profiles between FDG-positive cancers and polyps.
OUTLINE: Part I: Patients receive fludeoxyglucose F 18 (FDG) IV followed 45-60 minutes later by surgery to remove part or all of the colon. Tissue samples of the colon undergo positron emission tomography (PET) imaging.
Part II: Tissue samples are analyzed for glucose transporters proteins (Glut-1, 2, 3, 4, 5, 7) via IHC; presence of K-ras mutation (invariable mutant site on codon 12, 13) via PCR; 18q deletion via fluorescence in situ hybridization (FISH) or DCC IHC; MCT-1, Hex-1, Hex-2, and COX-2 expression levels via quantitative RT-PCR method or western blot; APC mutation via PCR- In Vitro Synthesized-Protein Assay or RT-PCR direct sequencing method; p53 mutation detection via immunochemistry, RT-PCR direct sequence methods, and western blot; methylation alteration of MGMT, CDKN2A, HLTF, MLH1, TIMP3, HIF1, BNIP3, and HRK via methylation detecting microchip; and specific gene methylations via methylation-specific PCR. Some tissue samples may be saved and banked for future studies.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
New York
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New York、New York、アメリカ、10065
- Memorial Sloan-Kettering Cancer Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Subject Inclusion Criteria:
- Patients eligible for entry into the study are those:
- Age 15 to 100
- Undergoing resection of a non-sarcomatous primary colon neoplasm who also has 2 or more adenomas each greater than or equal to 7-10mm in size which are anticipated to be removed with the colon specimen.
- It will be known from MSKCC or outside studies (barium enema, endoscopy, PET/CT, or CT colonography) that the patient has at least 2 proven adenomas 7-10 mm or greater and a primary colon neoplasm
Subject Exclusion Criteria:
- Insulin-dependent diabetics (as established by routine history and presurgical laboratory tests).
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
resection of a non-sarcomatous primary colon neoplasm
The surgically removed colon will undergo ex-vivo imaging after examination in pathology.
A PET scanner will be used to acquire a scan of the whole specimen.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Feasibility of ex-vivo imaging of colon cancer and colon polyps using fludeoxyglucose F 18 positron emission tomography (FDG PET)
時間枠：2 years
|
2 years
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Differences in molecular and genetic profiles between FDG-positive polyps and FDG-negative polyps to suggest what gene mutations and abnormal mRNA and/or protein expressions may be required for FDG avidity ("signature" for FDG avidity)
時間枠：2 years
|
2 years
|
|
Differences in molecular and genetic profiles between FDG-positive polyps and FDG-positive cancers to suggest what gene mutations and abnormal mRNA and/or protein expressions may be required for cancer formation ("signature" for cancer)
時間枠：2 years
|
2 years
|
|
Differences in molecular and genetic profiles between normal colonic mucosa, polyps, and cancer
時間枠：2 years
|
2 years
|
|
Differences and similarities in molecular and genetic profiles between FDG-positive cancers and polyps
時間枠：2 years
|
2 years
|
協力者と研究者
捜査官
- 主任研究者：Marc J. Gollub, MD、Memorial Sloan Kettering Cancer Center
- 主任研究者：Suresh Jhanwar, PhD、Memorial Sloan Kettering Cancer Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 07-114
- P30CA008748 (米国 NIH グラント/契約)
- MSKCC-07114
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