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[Ga-68]MTP220 PET for Biodistribution and Efficacy in Pancreatic Cancer and Head and Neck Cancers

ConditionsHead and Neck CancerPancreatic CancerCancer Pancreas
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorQiubai Li

About this trial

The goal of this research study is to develop a diagnostic tool to help with detection and diagnosis of head and neck cancer (HNC) and pancreatic cancer (PaC). This tool is called a "targeted PET tracer", or more specifically a drug named "\[Ga-68\]MTP220". The U.S. Food and Drug Administration (FDA) has not yet approved this drug, so researchers are conducting this research study to see if \[Ga-68\]MTP220 is safe and effective at diagnosing pancreatic cancer and head and neck cancer. FDA approval has been obtained for this study protocol by an Investigational New Drug (IND) application. Participants will receive a single injection of \[Ga-68\]MTP220 followed by PET/CT imaging at three points after they received the drug. These study procedures will take about 2.5 hours. Participants will also receive a follow-up phone call the day after receiving the drug to talk about any side effects they experienced.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants older than 18 years old

Prior biopsy showing pancreatic or head and neck malignancy

Participants have been newly diagnosed and not yet received definitive therapy (including surgery, radiation therapy, or systemic therapy).

Able and willing to provide written informed consent before any protocol-specific procedures are undertaken

Disqualifiers

Participants who do not meet the above mentioned inclusion criteria

Participants with severe hepatic and renal dysfunction (Total bilirubin > 3 mg/dL, Albumin < 2.8 g/dL, INR > 2.3 (or prolonged PT), presence of ascites or hepatic encephalopathy (Grade III-IV) End-Stage Renal Disease (ESRD) or eGFR < 30 mL/min/1.73m², Serum creatinine > 4 mg/dL or rapidly rising, Need for dialysis (hemodialysis or peritoneal dialysis), uremic symptoms)

Participants < 18 years old

Participants who refuse to give or are unable to sign the informed consent

Trial design

Design model

Single group

Treatments tested in this trial

  • [Ga-68]MTP220 PET/CT Scan

    Drug

    Participants will undergo PET/CT imaging after they have received an injection of the targeted PET tracer drug, \[Ga-68\]MTP220.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: [Ga-68]MTP220 PET/CT ImagingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Biodistribution of [Ga-68]MTP220 in patients with pancreatic cancer and head and neck cancers, as measured by standardized uptake value (SUV) mean and maximum

Time frame
Time it takes to do imaging study procedures, about 2.5 hours
2

Radiation dosimetry of [Ga-68]MTP220, as measured by dosimetry calculations performed using site software

Time frame
Time it takes to do imaging study procedures, about 2.5 hours

Secondary outcomes

1

Safety of [Ga-68]MTP220, as measured by number of participants who experience adverse events (AEs)

Time frame
Participants will be asked to report AEs via telephone follow-up no more than 1 day after they undergo study imaging
2

Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in blood pressure

Changes from baseline for vital signs may be tested for differences from zero by time point using ANOVA or paired t-test

Time frame
Baseline (10 minutes before dose) and at the following points after they received the dose: 10, 50, 90, 140 minutes
3

Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in heart rate

Changes from baseline for vital signs may be tested for differences from zero by time point using ANOVA or paired t-test

Time frame
Baseline (10 minutes before dose) and at the following points after they received the dose: 10, 50, 90, 140 minutes
4

Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in respiratory rate

Changes from baseline for vital signs may be tested for differences from zero by time point using ANOVA or paired t-test

Time frame
Baseline (10 minutes before dose) and at the following points after they received the dose: 10, 50, 90, 140 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qiubai Li

Lead sponsor

Case Comprehensive Cancer Center

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: