New scan could sharpen view of rectal cancer during treatment
NCT ID NCT05245786
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a special PET scan that uses a radioactive tracer (64Cu-M5A) to highlight rectal cancer cells. The goal is to see if this scan can show tumor extent and response more accurately than standard imaging before and after chemotherapy and radiation. About 14 adults with locally advanced rectal cancer will participate. The study focuses on improving detection, not on treating the disease directly.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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14 people
The number who actually took part.
- Started
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Aug 2022
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have histologically confirmed CEA expressing locally advanced rectal cancer (T3, T4 and N0 or N plus \[+\]) * Patients must be 18 years of age or older * The effects of 64Cu-M5A on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence} prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately * Patients must have a known site of disease. Patients must be scheduled to undergo neoadjuvant chemotherapy and radiation therapy followed by surgery * Patients who are planned for total neoadjuvant therapy where additional chemotherapy is planned before neoadjuvant chemoradiotherapy (CRT) are also eligible * Although not mandated by the protocol, the results of the computed tomography (CT), magnetic resonance imaging (MRI) and fludeoxyglucose F-18 (FDG) PET scans and labs (blood cell count \[CBC\], comprehensive metabolic panel \[CMP\]) that are performed as part of the standard work up should be available and should have been done within 2 months prior to study entry * All subjects must have the ability to understand and the willingness to sign a written informed consent * Prior therapy (chemotherapy, immunotherapy, radiotherapy) must be completed at least 2 weeks prior to infusion of radiolabeled antibody Exclusion Criteria: * Patients should not have any uncontrolled illness including ongoing or active infection * Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy * History of allergic reactions attributed to compounds of similar chemical or biologic composition to 64Cu-M5A * Pregnant women are excluded from this study because 64Cu-M5A is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with \^64Cu-M5A, breastfeeding should be discontinued if the mother is treated with 64Cu-M5A * Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope Medical Center
Duarte, California, 91010, United States
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