Lung Cancer Clinical Trial

A Multi – Center Study Of PET Imaging With [F-18] FLT & [F-18] FDG in Cancer Patients for Treatment Evaluation

Summary

Approximately 60 patients will be enrolled with highly suspected lung cancer, or head and neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen (except with 5-fluorouracil). The patients will undergo 3 visits. One screening, one pre therapy PET/CT imaging visit, and one (3-5 weeks after the start of therapy) post PET/CT imaging visit. This study will evaluate the FLT and FDG images for tumor proliferation rates for early assessment of tumor response to radiation or chemo-radiation combo.

View Full Description

Full Description

PHASE: II/III

OBJECTIVES:

Primary: To investigate the clinical value of serial quantitative [F-18] FLT positron image assessment of tumor proliferation rates for early assessment of tumor response to radiation or chemoradiotherapy regimens (except with 5-fluorouracil) in comparison to serial quantitative [F-18] FDG images

Secondary: To gain additional clinical information and experience with [F-18]FLT to guide the design of a future, pivotal, Phase III trial where changes in tumor proliferation from pre-treatment baseline values can be used as a early indicator of response to therapy regimens.

DESIGN: Open label, nonrandomized, uncontrolled, single group assignment

DURATION: Pre treatment [F-18] FLT PET scan following a clinical [F-18] FDG PET scan followed by post treatment [F-18] FLT PET scan and a post treatment, clinical [F-18] FDG PET scan at 4 weeks (±1 week) to monitor radiotherapy or chemoradiotherapy.

PROCEDURES: Informed consent, collection of demographic information, medical history, physical examinations, vital signs, 12-lead ECGs, concomitant medication collection, monitor adverse events, pre treatment [F-18] FLT PET scan and post treatment [F-18] FLT PET scan

SUBJECTS: Approximately 60 patients will be enrolled with confirmed lung cancer, or head and neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen (except with 5-fluorouracil) to be eligible. This allows for approximately 40 evaluable patients to complete this study at approximately four to eight sites and conducted in the United States.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patient provides written Informed Consent and is willing to comply with protocol requirements
Patient is at least 18 years of age on the day of dosing (male or female of any race or ethnicity)
Patient is capable of lying still in the PET scanner for the protocol required time frame(s)
Patient has a diagnosis of one of the following malignancies using the TNM Staging System:
Lung cancer (T3 grade up, node positive, but no metastatic disease)
Head and neck cancer (T3 grade up, node positive, but no metastatic disease)
Patient has undergone a comparative, diagnostic procedure with lesion(s) visible, other than ultrasound, that includes, but is not limited to computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine imaging, endoscopy, laparoscopy, standard abdominal x-ray, biopsy and/or surgery for one of the above mentioned areas
Patient is scheduled to start radiotherapy or a chemoradiotherapy regimen for curative intent
As a part of his/her standard radiotherapy or chemoradiotherapy regimen, patient is scheduled to have clinical [F-18]FDG PET scans pre treatment and post treatment (at about 4 weeks (±1 week) after the start of therapy)
Patient is scheduled to have the investigational, pre treatment [F-18] FLT PET scan recommended to be within ± 2 days of the clinical, pre treatment [F-18] FDG PET scan
Patient has not received or intends to receive 5-fluorouracil (chemotherapeutic agent)
Patient has a score of greater than or equal to (>/=) 60% on the Karnofsky Performance Status Scale

Exclusion Criteria:

Patient is a pregnant or lactating female. Exclude the possibility of pregnancy:
by testing on site at the institution (serum or urine βHCG) within 48 hours prior to the start of each investigational product administration
by surgical history (eg, tubal ligation or hysterectomy)
by patient's history of being post menopausal with a minimum 1 year without menses
Patient is undergoing treatment with palliative intent
Patient has received an investigational compound and/or medical device within 14 days before admission into this study
Patient has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
Patient is determined by the Investigator that he/she is clinically unsuitable for the study.

Study is for people with:

Lung Cancer

Estimated Enrollment:

49

Study ID:

NCT00847509

Recruitment Status:

Completed

Sponsor:

Siemens Molecular Imaging

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 2 Locations for this study

See Locations Near You

Hoag Memorial Hospital
Newport Beach California, 92658, United States
Excel Diagnostics Imaging Clinics
Houston Texas, 77042, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

49

Study ID:

NCT00847509

Recruitment Status:

Completed

Sponsor:


Siemens Molecular Imaging

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider