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Study of 18F-Fluoro-PEG6-IPQA

2016年6月23日 更新者:M.D. Anderson Cancer Center

A Phase I Study of 18F-Fluoro-PEG6-IPQA as a PET Imaging Agent for Active/Mutant EGFR Expression in Tumors

The goal of this clinical research study is to learn if an imaging solution called 18F-PEG6-IPQA can help to find tumors when used in positron emission tomography (PET) scans. The safety of the solution and how the solution is processed by your body will also be studied.

調査の概要

詳細な説明

18F-PEG6-IPQA is a solution that is designed to be attracted to tumor cells. The imaging solution has a small dose of radiation added to it, which may help doctors see the cancer cells better during imaging scans. This is the first study using 18F-PEG6-IPQA in humans.

Study Imaging:

If you are found to be eligible to take part in this study, you will visit the clinic on Day 1 for the injection of the study solution and PET scans. This imaging study will be performed at FDA-cleared PET-CT scanners at MD Anderson sites, including at the Center for Advanced Biomedical Imaging (CABI).

For up to 6 hours before the PET scans and computed tomography (CT) scans, you must not eat or drink anything except water. This is called fasting.

A small tube will be placed in your arm and you will receive an injection of 18F-PEG6-IPQA.

After the injection, scanning will begin immediately. You will have 3 PET scanning sessions with a PET/CT scanner. Before each PET scan, you will have a CT scan to make sure you are in the right position for the PET scans. Each PET scan may last up to 1 hour. Each positioning CT scan should take about 5 minutes. You will have a 10 minute "rest period" between each PET scan.

Study Visits:

On Day 1:

  • Before the imaging solution is injected, your vital signs and an ECG rhythm strip will be collected. The study staff will insert an intravenous (IV) needle and line into each of your arms.
  • Right after the injection of the study drug, blood (about 2 tablespoons total) will be drawn for pharmacokinetic (PK) testing from one of the existing IV lines. PK testing measures the amount of study solution in the body at different time points. Blood will be drawn at 1, 3, 8, 16, 30, 45, 60, 90, and 150 minutes after the injection of 18F-PEG6-IPQA for a total of 9 draws.
  • About 30 minutes after the injection, your vital signs will be measured and the injection site will be checked.
  • Urine will be collected during the 10 minute rest periods in between scans or at the completion of the 3-hour scanning period.
  • After the scans are completed (about 3 hours after the injection) your vital signs and injections site will be checked again, and you will have an ECG rhythm strip taken. Blood (about 2 tablespoons) and urine will also be collected for routine tests.

On Days 2 and 7:

  • Blood (about 2-3 tablespoons) will be drawn for routine tests.
  • Your vital signs and the injection site will be checked
  • You will be asked about any side effects you may be having since the injection.

End-of-Study Visit:

The end-of-study visit will be about 14 days after the injection of 18F-PEG6-IPQA and imaging scans. The following tests and procedures will be performed:

  • Blood (about 2-3 tablespoons) will be drawn for routine tests.
  • You will have a physical exam, including measurement of your vital signs.
  • The injection site will be checked.
  • You will have an ECG.

Length of Study:

You will be in this study for about 14 days. You will be taken off study early if intolerable side effects occur.

This is an investigational study. 18F-PEG6-IPQA is not FDA-approved or commercially available for use in imaging scans. Its use in this study is investigational.

The scans performed with 18F-PEG6-IPQA are also considered investigational and will not be used for planning any of your future cancer treatment.

Up to 15 patients will take part in this study. All participants will be enrolled at MD Anderson.

研究の種類

介入

入学 (実際)

6

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Texas
      • Houston、Texas、アメリカ、77030
        • University of Texas MD Anderson Cancer Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. All patients must give written informed consent
  2. Patients should have pathologically or cytologically confirmed Stage IV non-small cell lung cancer with clinical or radiological evidence that it is not amenable to therapy with curative intent. Prior EGFR tyrosine kinase inhibition (TKI) therapy is permitted but not required.
  3. Patients should be potential candidates for therapy with an EGFR tyrosine kinase inhibitor or with an anti-EGFR monoclonal antibody by clinical criteria.
  4. Patients should have clinical characteristics that would suggest an increased probability of benefit from an EGFR inhibitor. Specifically, they should have known EGFR mutations or high gene copy number.
  5. Patients should have at least one tumor deposit that is > 1.0 cm in diameter, and that is amenable to imaging
  6. Patients should be Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  7. Patients with brain metastases are eligible provided they meet all other eligibility criteria and do not require corticosteroids or enzyme-inducing anticonvulsants and provided it is felt clinically that they will not require radiotherapy in the three (3) weeks subsequent to their participation in the study
  8. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Childbearing potential will be defined as women who have had menses within the past 12 months, who have not had tubal ligation or bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately. The patient, if a man, agrees to use effective contraception or abstinence
  9. The patient must be considered legally capable of providing his or her own consent for participation in this study
  10. Subjects must be at least 18 years of age

Exclusion Criteria:

  1. Radiotherapy, chemotherapy or any investigational agent within the previous 2 weeks of administrating 18F-PEG6-IPQA for PET/CT imaging.
  2. A non-investigational targeted agent within the previous 2 weeks of 18F-PEG6-IPQA for PET/CT imaging.
  3. Thoracic or abdominal surgery within the previous 2 weeks of 18F-PEG6-IPQA for PET/CT imaging.
  4. A tumor that is known to have a K-ras mutation
  5. Squamous cell, large cell undifferentiated, neuroendocrine or small cell undifferentiated carcinoma of the lung
  6. A known other currently active malignancy. (Benign tumors and benign polyps, basal cell carcinomas of skin, superficial papillary bladder tumors, and pre-invasive carcinoma of the cervix are permitted)
  7. Physical inability to undergo a scanning procedure (e.g., inability to lie flat for the required period of time - three sessions of roughly an hour each with ten minutes' rest in between)
  8. Serum creatinine >1.5 x upper limit of normal (ULN), bilirubin >1.5 x ULN, AST > 3 x ULN
  9. 10. Hemoglobin < 8 g/dL, absolute neutrophil count < 1,500/mm3, platelet count <100,000/mm3
  10. Potentially life-threatening arrhythmia; myocardial infarct within the previous 3 months; unstable angina, or angina at rest; congestive heart failure (New York Heart Association Functional Classification class II or worse), uncontrolled hypertension (systolic BP > 160 or diastolic BP >100).
  11. Active acute infection (i.e. currently treated with antibiotics). Patients with chronic infections such as hepatitis B or C, mycobacterium avium or similar infections will be eligible provided they meet all other eligibility criteria.
  12. Oxygen saturation <90% on room air
  13. Clinical requirement for systemic corticosteroids for control of cerebral edema or for enzyme-inducing anticonvulsants. (Inhaled steroids and systemic steroids for chronic obstructive pulmonary disease (COPD) are permitted).
  14. Pregnant or nursing
  15. Any condition that is unstable or could jeopardize the safety of the patient and his or her compliance in the study, in the investigator's judgment

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:診断
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Imaging with 18F-PEG6-IPQA
Radioactive injection given by vein before multiple (3) PET scans.
Radioactive injection (PET imaging agent) given by vein before PET scans.
3 PET scans performed after injection and positioning CT. Imaging should take about 3 hours.
他の名前:
  • ペット
  • イメージング

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
メジャーの説明
時間枠
Optimum dosimetry of 18F-PEG6-IPQA sodium injection based on critical organ safety
時間枠:Safety measurements performed from administration of injection until 2 weeks after administration.
Optimum dosimetry of 18F-PEG6-IPQA injection for each cohort derived from previous cohort based on statistical evaluation of critical organ exposure and safety limitations. Safety measurements performed from administration of 18F-PEG6-IPQA injection until 2 weeks after administration. The biodistribution of 18F-PEG6-IPQA will be measured during positron emission tomography (PET) scans. The percent injected dose (%ID) obtained in different organs will be derived from the PET data.
Safety measurements performed from administration of injection until 2 weeks after administration.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Donald Podoloff, MD,BA、M.D. Anderson Cancer Center

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2012年2月1日

一次修了 (実際)

2016年4月1日

研究の完了 (実際)

2016年4月1日

試験登録日

最初に提出

2011年3月18日

QC基準を満たした最初の提出物

2011年3月18日

最初の投稿 (見積もり)

2011年3月22日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年6月27日

QC基準を満たした最後の更新が送信されました

2016年6月23日

最終確認日

2016年4月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 2009-0832
  • W81XWH-05-2-0027 (その他の助成金/資金番号:Department of Defense)
  • NCI-2014-01375 (レジストリ識別子:NCI CTRP)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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