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

This study is currently recruiting participants.
Verified May 2012 by AHS Cancer Control Alberta
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT01065805
First received: December 19, 2008
Last updated: May 31, 2012
Last verified: May 2012

December 19, 2008
May 31, 2012
February 2009
December 2015   (final data collection date for primary outcome measure)
  • Phase I: to determine the safety of 18 F-FLT. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01065805 on ClinicalTrials.gov Archive Site
  • Phase I: To determine general biodistribution of 19F-FLT [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Demonstrate the Safety and Preliminary Efficacy of 18F-FLT in Patients With Solid Tumours or Lymphoma
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

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Brain Cancer
  • Cancer
  • Solid Tumor
  • Lymphoma
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

Experimental: 1
18F-FLT PET
Intervention: Biological: 18F-FLT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
170
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact: Lai Schrader (780) 432 - 8464 Lai.Schrader@albertahealthservices.ca
Contact: Margaret Landon (780) 432-8751 Margaret.Landon@albertahealthservices.ca
Canada
 
NCT01065805
SP-24513/DX-FLT-002
No
AHS Cancer Control Alberta
AHS Cancer Control Alberta
Not Provided
Principal Investigator: Alexander J. B. McEwan, MB, BS, MSc Cross Cancer Institute
AHS Cancer Control Alberta
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP