Clinical trial · Interventional
111 Indium CHX-A DTPA Trastuzumab (Indium-Herceptin) for Imaging Breast Cancer
A Phase 0 Trial of (111)Indium CHX-A DTPA Trastuzumab Imaging in Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: * Some breast cancer cells have specific proteins (receptors) on their surface that make the tumor grow faster than normal cells. One of these receptors is called HER2/neu. * An FDA-approved drug called Herceptin attaches to HER2/neu if it is present on the cancer cell. * Indium-Herceptin is an agent in which a tiny amount of radioactivity called Indium has been attached to a tiny amount of Herceptin. Objectives: -To see if Indium-Herceptin provides information about the characteristics of the breast cancer in women whose tumors express HER2/neu and those whose tumors do not. Eligibility: -Women 18 years or older with primary or metastatic breast cancer who have not received treatment with herceptin for at least 6 months before enrollment into the study. Design: * Tissue from the patient s original breast or tumor biopsy is analyzed for HER2/neu status. * Patients have a physical examination and review of medical records. * Patients receive an injection of Indium-Herceptin, followed by scanning with a gamma camera that detects the radioactivity in the Indium-Herceptin. * Patients return to the clinic 1, 2, 3 and 7 days later for repeat imaging to determine the best time to image after injection of Indium-Herceptin. * Blood samples are obtained every day of scanning to monitor the effects, if any, of the Indium-Herceptin and to see how fast the agent leaves the body.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 111Indium CHX-A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1-Arm 1
- description
- Subjects with primary or metastatic cancer other than melanoma, basal cell carcinoma, sarcoma, or lymphoma.
- interventionNames
- Drug: 111Indium CHX-A
Primary outcomes (1)
- measure
- Compare uptake of 111Indium-CHX-A DTPA trastuzumab with HER2/Neu (ErbB2) status of the tumor as determined by IHC
- timeFrame
- 5 days after intervention
- description
- Correlation between uptake of 111Indium-CHX-A DTPA trastuzumab with HER2/Neu (ErbB2) and status of the tumor as determined by IHC
Secondary outcomes (5)
- measure
- Safety of 111Indium-trastuzumab.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
* INCLUSION CRITERIA: Participant must have histological confirmation of primary or metastatic cancer other than melanoma, basal cell carcinoma, sarcoma, or lymphoma. * Primary tumor or metastatic focus must be 1.5cm or greater in diameter as established by palpation, ultrasound, mammography, CT or MRI. * Participant must be 18 years or older. * Availability of tumor tissue (either from the initial primary tumor or from current tumor lesion) for performing IHC or FISH analysis for HER2/Neu (Erb2) * Chemistry and CBC parameters: serum creatinine less than or equal to 1.4mg/dl. SGOT and SGPT less than or equal to 3 times of the upper limits of normal; total bilirubin, of less than or equal to 2 times the upper limits of normal or 3.0 mg/dl in patients with Gilbert s syndrome; platelet count must be greater than 100,00. * ECOG Performance score of 0 or 1. * Ability to provide informed consent. * Negative serum pregnancy test (within 48 hours of imaging agent injection) in women of child bearing age and willingness to use contraception (barrier, abstinence, non-hormonal) for 3 weeks after injection of (111)Indium trastuzumab if participant is of child bearing age. EXCLUSION CRITERIA: * Known allergy to trastuzumab. * Pregnant or lactating women. * Participants for whom enrollment would significantly delay (greater than 2 weeks) the scheduled standard of care therapy. * Participants with an active second malignancy (excluding treated basal cell skin carcinoma). * History of cardiac disease (myocardial infarction, arrhythmias requiring therapy, symptomatic valvular disease, cardiomyopathy, or pericarditis). * Participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results. * Participants with severe claustrophobia. * A participant who needs a nuclear medicine scan other than a PET scan as part of their work-up cannot enroll until these scans have been completed. * Gamma-camera table restrictions preclude scanning participants greater than 350 lbs (160 Kg) * With the exception of AT13387 and PU-H71, and Ad5f35HER2ECTM transduced autologous dendritic cell vaccine participants cannot have received another experimental drug within 14 days prior to or during study enrollment.
References
Publications (3)
- BACKGROUNDMilenic DE, Garmestani K, Brady ED, Albert PS, Ma D, Abdulla A, Brechbiel MW. Targeting of HER2 antigen for the treatment of disseminated peritoneal disease. Clin Cancer Res. 2004 Dec 1;10(23):7834-41. doi: 10.1158/1078-0432.CCR-04-1226. PMID 15585615
- BACKGROUNDPegram MD, Pauletti G, Slamon DJ. HER-2/neu as a predictive marker of response to breast cancer therapy. Breast Cancer Res Treat. 1998;52(1-3):65-77. doi: 10.1023/a:1006111117877. PMID 10066073
- BACKGROUNDMenard S, Casalini P, Campiglio M, Pupa S, Agresti R, Tagliabue E. HER2 overexpression in various tumor types, focussing on its relationship to the development of invasive breast cancer. Ann Oncol. 2001;12 Suppl 1:S15-9. doi: 10.1093/annonc/12.suppl_1.s15. PMID 11521715