A Study to Demonstrate the Safety and Preliminary Efficacy of 18F-FLT in Patients With Solid Tumours or Lymphoma

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The Radiotracer 18F-FLT can non-invasively assess excessive cell growth in PET scan images. Tumour growth rate is a useful indicator of tumour aggression and response to treatment. Imaging and measuring the cell growth with 18F-FLT may be useful in monitoring response to anticancer treatment.

Condition or disease	Intervention/treatment	Phase
Brain Cancer; Cancer; Solid Tumor; Lymphoma	Biological: 18F-FLT	Phase 1; Phase 2

Detailed Description:

Clinical trial is a combined Phase I/II imaging, open label, single site study in patients with known or suspected carcinoma of the lung, breast, renal cell, pancreas or brain, and with gastrointestinal malignancies, neuroendocrine tumours, or lymphoma. One 18F-FLT PET scan will be performed in 10 Phase I patients, and pre-injection and post-imaging blood work and vital signs will be collected. Up to 5 18F-FLT PET scans will be performed in 170 Phase II patients.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	170 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	A Contiguous, Sequential Phase I/II Imaging Study of 18F-fluoro-3'-L-fluorothymidine (18F-FLT)in Patients With Known or Suspected Carcinoma of the Lung, Breast, Renal Cell, Pancreas, or Brain, and With Gastrointestinal Malignancies, Neuroendocrine Tumours or Lymphoma
Study Start Date :	February 2009
Estimated Primary Completion Date :	December 2015
Estimated Study Completion Date :	December 2015

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; 18F-FLT PET	Biological: 18F-FLT; Phase I: Radioactive dose of 2.59 MBq/kg (111-222 MGq)per injection. A single injection of 18F-FLT and PET scan will be permitted per patient. Phase II: Radioactive dose of 2.59 MBq/kg (100-350) MBq per injection. Up to five separate injections of 18F-FLT and PET scans will be permitted per patient

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Phase I: to determine the safety of 18 F-FLT. [ Time Frame: 3 years ]
2. Phase II: To determine general biodistribution of 18F-FLT and correlate 18F-FLT uptake with hENT1 expression and Ki-67 scores. [ Time Frame: 3 years ]

Secondary Outcome Measures :

1. Phase I: To determine general biodistribution of 19F-FLT [ Time Frame: 3 years ]
2. Phase II: to confirm safety of 18F-FLT; to determine the relative uptake of 18F-FLT (SUV, RUS, T/N); and to correlate 18F-FLT uptake with patient outcomes. [ Time Frame: 3 years ]
3. Phase II: to correlate 18F-FLT uptake with patient outcomes (treatment response, progression-free survival, overall survival), over the first 12 months of follow-up after completion of tx, subsequently over the remainder of the disease course [ Time Frame: 3 years ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Male or female greater than or equal to 16 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of last menstrual period, a negative pregnancy test is required.
• Patients with known primary or suspected primary, recurrent or metastatic carcinoma of the lung, breast, renal cell, pancreas or brain (including GGM, oligodendrogliomas, and brain metastases from any primary tumour) and with gastrointestinal malignancies, neuroendocrine tumours (including carcinoid and islet cell malignancies, or lymphoma, with at least one lesion >1 cm in diameter.
• Biochemical parameters as measured are required to be within 5 times the normal limits for age.
• Able and willing to follow instruction and comply with the protocol
• Provide written informed consent prior to participation in the study
• Karnofsky Performance Scale Score 50-100

Exclusion Criteria:

• Previous removal of entire tumour
• Biochemical parameters as measured outside 5 times the normal limits for age
• Unable or unwilling to follow instructions and comply with the protocol
• Unable or unwilling to provide written informed consent prior to participation in the study
• Karnofsky Performance Scale Score < 50
• Nursing or pregnant females
• Age less than 16 years

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Lai Schrader	(780) 432 - 8464	Lai.Schrader@albertahealthservices.ca

Locations

Canada, Alberta
Cross Cancer Institute	Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Principal Investigator: Alexander J. B. McEwan, MD
Sub-Investigator: M ichael B Sawyer, MD
Sub-Investigator: Andrew R Belch, MD
Sub-Investigator: John Mercer, BSc, MSc, PhD
Sub-Investigator: Emmanuel Hudson, BMedSc, MD

Sponsors and Collaborators

AHS Cancer Control Alberta

Investigators

Principal Investigator:	Alexander J. B. McEwan, MB, BS, MSc	Cross Cancer Institute

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Related Info 

Responsible Party:	AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:	NCT01065805 History of Changes
Other Study ID Numbers:	SP-24513/DX-FLT-002
First Posted:	February 9, 2010
Last Update Posted:	June 12, 2014
Last Verified:	June 2014

Keywords provided by AHS Cancer Control Alberta:

18F-FLT; Positive Emission Tomography; Cancer

Additional relevant MeSH terms:

Lymphoma; Brain Neoplasms; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Central Nervous System Neoplasms	Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Alovudine; Antiviral Agents; Anti-Infective Agents