In Vivo Assessment of Hypoxia in Gastro-intestinal Cancer Using 18F-HX4-PET: an Optimization and Reproducibility Study

NCT01995084 | Completed

• 1 other identifier: NL40274.018.12
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Several studies have shown that tumour hypoxia may have a negative impact on the outcome of anticancer treatment. Assessment of tumor hypoxia at baseline or shortly after start of treatment may serve as a predictive marker to determine treatment efficacy at an early stage. Preferably, such an assessment is performed in vivo and non-invasively.Non-invasive imaging with positron emission tomography (PET) using the 2-nitroimidazole nucleoside analogue, 3-18F-fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1- yl)propan-1-ol (18F-HX4), was tested as a new marker of tumor hypoxia. Before hypoxia-measurements can be clinically implemented for response prediction, the reproducibility of the technique should be assessed for each specific tumor type. Knowledge of reproducibility is needed to determine what change in parameters between two examinations can be considered relevant in an individual patient. Assessment of reproducibility becomes even more important in early response monitoring since the changes in the tumor induced by the treatment may be smaller during the treatment compared to response monitoring after completion of treatment. Also, as image quality of 18F-HX4-PET increases with increasing time intervals after injection, determination of the optimal time point for measurement of hypoxia is warranted.

Conditions

Pancreatic Cancer; Esophageal Cancer; Rectal Cancer

Keywords

hypoxia; HX4; PET; cancer

Outcome Measures

Primary Outcomes (2)

• Reproducibility of SUV measured with 18F-HX4 PET

  Tumor SUVmean, SUVmax, Uptake Ratio

  Within 10 days

• Optimal time frame between administration of 18F-HX4 and PET scan

  Tumor SUVmean, SUVmax, Uptake Ratio

  2-4h after injection

Study Arms (2)

Optimization

EXPERIMENTAL

Patients undergo a \[F-18\]HX4 PET/CT scan 2,3 and 4h after \[F-18\]HX4 injection.

Drug: [F-18]HX4

Reproducibility

EXPERIMENTAL

Patients undergo two \[F-18\]HX4 PET/CT scans 3.5h after \[F-18\]HX4 injection within a 10-day time frame.

Drug: [F-18]HX4

Interventions

[F-18]HX4 DRUG

400 MBq \[F-18\]HX4, is administered in a single intravenous bolus injection, followed by a saline flush.

Also known as: [18 F]-3-Fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-, 1H-1,2,3-triazol-1-yl)propan-1-ol

Optimization; Reproducibility

Eligibility Criteria

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

You may qualify if:

• Patients with biopsy proven invasive carcinoma of the esophagus, pancreas or rectum. In pancreatic cancer cytological proof or a high suspicion on CT imaging is allowed, too.
• Tumor size ≥ 1cm
• WHO-performance score 0-2
• Written informed consent

You may not qualify if:

• Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol.
• Surgery, radiation and/or chemotherapy foreseen within the timeframe needed for two PET scans.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Esophageal Neoplasms; Rectal Neoplasms; Hypoxia; Neoplasms

Interventions

3-fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1-yl)propan-1-ol

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Intestinal Diseases; Rectal Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: November 26, 2013
• Study Start: May 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

NL (1)