ClinicalTrials.gg
CompletedNCT00661154Updated Aug 10, 2012

Avastin/[18-F]-5-fluorouracil PET/CT Imaging Feasibility Project

An observational study in Colorectal Neoplasms, Colon Cancer and Rectal Cancer, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-10.

Sponsored by Stanford University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7
Ages
18 Years and older
Sex
All
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Study summary

To determine whether using a radiolabelled analog of 5-FU, [18F]-5-fluorouracil, for PET/CT imaging can visually demonstrate differential chemotherapy delivery to known tumor sites before and after administration of bevacizumab and determine the optimal timing of bevacizumab administration to maximize the chemotherapy delivery into the tumor for improved cancer treatment.

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Conditions studied

  • Colorectal Neoplasms
  • Colon Cancer
  • Rectal Cancer
  • Anal Cancer
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In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's enrollment of 7 is below the median of 250 across 1,253 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Stanford University is the lead sponsor of 2,161 studies on the registry; 428 are open to participants now.

Of its 268 completed or terminated interventional studies of FDA-regulated products, 207 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with metastatic (stage IV) colorectal cancer

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients must have histologically or cytologically confirmed adenocarcinoma of the colon.
  2. Patients must have metastatic disease to the liver with at least one lesion that is measurable by RECIST criteria within 4 weeks prior to entry of study
  3. Patients with a history of colon adenocarcinoma treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless an interval of > 5 years has elapsed between the primary surgery and the development of metastatic disease. Clinicians should consider biopsy of lesions to establish diagnosis of metastatic colon adenocarcinoma if there is substantial clinical ambiguity regarding the nature or source of apparent metastases.
  4. Patients must have ECOG performance status of 0-2
  5. Patients must be >= 18 years of age
  6. Laboratory values \<= 2 weeks prior to enrollment:

    • Absolute Neutrophil Count (ANC) >= 1.5 x 10\^9/L (>= 1500/mm\^3)
    • Platelets (PLT) >= 100 x 10\^9/L >= 100,000/mm\^3)
    • Hemoglobin (Hgb) >= 9 g/dL
    • Serum creatinine \<= 1.5 ULN
    • Serum bilirubin \<= 1.5 ULN
    • Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) \<= 3.0 x ULN (\<= 5 x ULN if liver metastases present). Note: ERCP or percutaneous stenting may be used to normalize the liver function tests.
    • Negative for proteinuria based on dip stick reading OR, if documentation of +1 result for protein on dip stick reading, then total urinary protein \<= 500 mg and measured creatinine clearance (CrCl) >= 50 mL/min from a 24-hour urine collection
  7. Life expectancy >= 12 weeks
  8. Ability to give written informed consent according to local guidelines

Exclusion criteria

Exclusion Criteria:

  1. Patients receiving prior 5-FU for the treatment of metastatic colorectal adenocarcinoma will be excluded from enrollment. Previous use of 5-FU for adjuvant treatment of resected stage II or III colorectal adenocarcinoma will be allowed, provided the time from last 5-FU administration to enrollment is > 3 months.
  2. Prior full field radiotherapy \<= 4 weeks or limited field radiotherapy \<= 2 weeks prior to enrollment. Patients must have recovered from all therapy-related toxicities. The site of previous radiotherapy should have evidence of progressive disease if this is the only site of disease.
  3. Prior biologic or immunotherapy \<= 2 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
  4. Prior therapy with anti-VEGF agents
  5. Patients with a history of another primary malignancy \<= 5 years, with the exception of inactive basal or squamous cell carcinoma of the skin
  6. Concurrent use of other investigational agents and patients who have received investigational drugs \<= 4 weeks prior to enrollment.
  7. Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. Barrier contraceptives must be used throughout the trial in both sexes. Women of childbearing potential must have a negative serum pregnancy test 48 hours prior to administration of study treatment.
  8. Patients unwilling to or unable to comply with the protocol
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7 participants (actual)

Interventions

  • 2-12microCi IV injection

    Also known as: Avastin

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What researchers measure

Primary outcomes

  1. Determine whether[18F]-5-Fluorouracil PET/CT scanning can demonstrate a difference in [18F]-5-Fluorouracil tumor uptake before and after the administration of Avastin

    Time frame: 1-4 days

Secondary outcomes

  1. Determine if [18F]-5-Fluorouracil PET/CT imaging demonstrates that there is a difference in maximal [18F]-5-Fluorouracil tumor uptake that is dependent on the time point of post-Avastin scanning

    Time frame: 1-4 days

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Study locations

1 site
  • Stanford University School of Medicine
    Stanford, California 94305, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00661154
Collaborators
Genentech, Inc.
Responsible party
Sponsor
First posted
Apr 18, 2008
Start date
Feb 2008
Primary completion
Jul 2009
Completion
Jul 2010
Last update
Aug 10, 2012

Study contacts

Dr Andrew Quon
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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