NCT01065805

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

March 20, 2009

Completed
11 months until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2019

Completed
Last Updated

August 22, 2019

Status Verified

February 1, 2019

Enrollment Period

9.9 years

First QC Date

December 19, 2008

Last Update Submit

August 21, 2019

Conditions

Brain CancerCancerSolid TumorLymphoma

Keywords

18F-FLTPositive Emission TomographyCancer

Outcome Measures

Primary Outcomes (2)

  • Phase I: to determine the safety of 18 F-FLT.

    3 years

  • Phase II: To determine general biodistribution of 18F-FLT and correlate 18F-FLT uptake with hENT1 expression and Ki-67 scores.

    3 years

Secondary Outcomes (3)

  • Phase I: To determine general biodistribution of 19F-FLT

    3 years

  • 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.

    3 years

  • 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

    3 years

Study Arms (1)

1

EXPERIMENTAL

18F-FLT PET

Biological: 18F-FLT

Interventions

18F-FLTBIOLOGICAL

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

1

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Brain NeoplasmsNeoplasmsLymphoma

Interventions

alovudine

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Michael B Sawyer, MD

    Cross Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2008

First Posted

February 9, 2010

Study Start

March 20, 2009

Primary Completion

February 25, 2019

Study Completion

February 25, 2019

Last Updated

August 22, 2019

Record last verified: 2019-02

Locations

CA(1)