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

NCT00847509 | Completed Results

• 1 other identifier: FLT101
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Lung Cancer; Head and Neck Cancer

Keywords

lung cancer; head and neck cancer; radiotherapy; chemoradiotherapy; radiation; chemoradiation; FLT; [F-18]FLT; FDG; [F-18]FDG

Outcome Measures

Primary Outcomes (1)

• [F-18]FLT PET Scan for Early Assessment of Tumor Response to Radiation or Chemoradiotherapy Compared to [F-18] FDG PET Scan

  The sponsor decided not to further develop \[F-18\]FLT. Therefore, no further analysis was performed.

  3-5 weeks after the start of radiation or chemo radio therapy

Study Arms (1)

FLT PET scan

EXPERIMENTAL

Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate \[F-18\] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard \[F-18\] FDG PET will be the active comparator.

Drug: [F-18]FLT

Interventions

[F-18]FLT DRUG

The individual doses of \[F-18\]FLT contain a maximum of 10 mCi. The single IP dose is administered to the study subject approximately 30 to 60 minutes prior to the start of PET imaging.

Also known as: [F-18] FLT, FLT

FLT PET scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Siemens Molecular Imaging: lead

Study Sites (2)

Hoag Memorial Hospital

Newport Beach, California, 92658, United States

Location

Excel Diagnostics Imaging Clinics

Houston, Texas, 77042, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Head and Neck Neoplasms

Interventions

alovudine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Edward M. Aten, M.D.
• Organization: Certus International, Inc.

eaten@certusintl.com

603.627.1212

Study Officials

• Ebrahim S Delpassand, MD

  Excel Diagnostics Imaging Clinics

  PRINCIPAL INVESTIGATOR

• Michael Brandt-Zawadzki, MD

  Hoag Memorial Hospital, Newport Beach, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 19, 2009
• Study Start: February 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 27, 2013
• Results First Posted: September 27, 2013

Record last verified: 2013-07

Locations

US (2)